Shocker: Life-Saving Portable Defibrillator Movement Plagued By Malfunctions

Portable defibrillators seem so commonplace these days that people in danger of heart failure can buy one online for about $1,200. But the two-decade movement to make the life-saving devices as handy as fire extinguishers is all but flatlining.

Some analysts say the explosive growth that triggered a corporate frenzy of competition, innovation and dizzying mergers has been hindered by suspect quality control and machine malfunctions, which have led to the recalls of millions of the devices and hundreds of deaths-by-glitch.

The U.S. Food and Drug Administration’s database lists 16,586 voluntary complaints of malfunctioning portable defibrillators since 2007 through February, along with 24 Class 1 recalls of millions of the devices, including three recalls so far this year.

Class 1 recalls are those in which the malfunctioning product may result in death because it doesn’t work. There were 102 Class 2 recalls, which can cause injuries, during the same period.

“I think (the recalls) are the fault of the companies not following up on the complaints,” said Myron “Mike” Weisfeldt, M.D., chairman of the Johns Hopkins Department of Medicine and a former president of the American Heart Association. “There has to be more studies done.”

The Automated Electronic Defibrillators (AEDs), a relatively new technology, are designed so that anybody with basic — or, in a pinch — no training can administer a life-saving jolt of electricity to the heart of a person stricken with cardiac arrest, the world’s leading cause of death.

Defibrillators are best known from television medical shows, where an actor playing a doctor dramatically shouts “clear” and presses a pair of paddle-like electrodes to deliver a shock to the chest that brings a patient in cardiac back to the land of the living. Death can strike within 10 minutes unless the jolt of electricity is administered.

A team of researchers published a 2012 study in the Annals of Emergency Medicine that analyzed “adverse event reports” compiled by the FDA’s manufacturer and user device database. It said there were 1,150 failed defibrillation attempts that resulted in deaths from June 1993 and October 2008. It concluded that a quarter of those resulted from battery problems.

Company That Invented Defibrillators Plagued By Complaints, Recalls

The most profound symbol of the spasms in the defibrillator movement is Physio-Control, Inc., the company founded on Feb. 14, 1955, by Seattle cardiovascular surgeon Karl William Edmark, M.D., who invented the very concept of the electronic defibrillator.

Physio-Control, which was bought by Stryker Corporation SYK $1.28 billion in April 2016 after changing hands a half dozen times, has had thousands of complaints about malfunctioning AEDs since that sale, according to the FDA database. It had 22 total recalls since 2008.

One entry: Emergency medical personnel on Feb. 6 tried to revive a patient at an unidentified location with a Physio-Control LIFEPAK 15. “After a little less than 2 minutes, the monitor quit displaying the (heart) rhythm,” according to the FDA event report. “It instead displayed only dashed lines.”

The patient died. Four days later, the FDA issued a recall for 139 of the devices.

On March 8, the FDA issued another Class 1 recall for 50,046 LIFEPAK 1000 defibrillators nationwide “due to an electrical issue which may cause the device to shut down unexpectedly during patient treatment,” the FDA said. It came two months after Physio-Control had issued a voluntary recall of the machine based on 34 reports. “The company is aware of 8 adverse events related to this issue,” the company said.

Adverse events include death. On Feb. 13, 2014, 66-year-old Stephen Ricks slumped over the wheel of his car and drove up over a curb in the a Portland, Oregon, suburb of Hillsboro. Hillsboro fire and rescue spent 14 minutes unsuccessfully trying to get a Physio-Control LIFEPAK 12 to deliver a shock. The defibrillator eventually did deliver the shocks necessary to Ricks’ heart, but he died in the hospital nine days later.

Asked for comment on its information-rich recall record, a Physio-Control spokesperson said:

"Field Actions (recalls, repairs and instructions to correct flaws) are an important part of effective quality systems across the medical device industry. We have an enduring commitment to quality and will continue to support our customers in their lifesaving work."

Philips AED Issues Raise Analyst Concerns

Medical device giant Koninklijke Philips NV (ADR) PHG — better known as Royal Philips or just Philips — has had such a bad run of balky defibrillators that it may impact the bottom line. In December 2013, the FDA recalled 700,000 Philips HeartStart AEDs used on sites such as airports, schools, government buildings, community centers and households. Philips also revealed it was involved in “discussions” with the U.S. Justice Department regarding its AEDs, but said it was unrelated to the 2013 recall.

“We have made tremendous progress over the last two years in quality improvement,” Frans van Houten, Philips CEO, told concerned analysts in January during a conference call on the Q4 report. “Nevertheless, it is a little bump in the road that we need to deal with here.”

Houten said “the impact of the past inspections” will lead to “some impact in the business during 2017.” The massive company is still reeling from the shutdown of a plant in Cleveland that made shoddy medical imaging equipment.

Houten told analysts he couldn’t go into detail about the “discussions” with the Justice Department. On March 24, the FDA reported a new entry warning that 97,794 HeartStart MRx Monitor/Defibrillator are prone to malfunction.

Philips has had 56 recalls since 2007, the most of any manufacturer.

New FDA guidelines requiring clinical trials went into effect in August 2016, with new machine accessories not scheduled to be subject to clinical trials until 2020. The new rules came after a 2011 study that showed more than 70 percent of the 113 recalled models were cleared for market under a shorter FDA review process.

The study, published in the Archives of Internal Medicine, explored the most serious, life-threatening medical device recalls, from 2005 to 2009, including recalls of AEDs.

“Americans are dying and being harmed because their devices are not being tested before they are sold,” study co-author Diana Zuckerman, president of the National Center for Health Research, told the U.S. Senate Special Committee on Aging in 2011.

“You have to assume that these voluntary reports are just the tip of the iceberg,” she told Benzinga. “I just assume that a bystander or mall manager who might use this device are not going to know this reporting system exists.”

Balky Defibrillator A Prescription For Death

Philips and Physio-Control aren’t alone. FDA complaints about malfunctions have led to recalls or corrective actions of thousands of machines by ZOLL Medical Corporation ZOLL; Cardiac Science Corporation, acquired last year by the Aurora Capital Group private equity firm; HeartSine Technologies, Ltd., of Northern Ireland; Allyn Welch Holdings Inc.; and Defibtech, LLC, of Connecticut.

A sampling of recalls from the FDA database:

  • In 2009, Zoll recalled 80,000 AEDs after the deaths of two patients. The devices failed to detect defective batteries. 
  • Heartsine Technologies Ltd. had reported 3,800-plus malfunctions with its Samaritan devices between Sept. 28 of last year until Feb. 20 of this year, despite a recall of the model in 2012, when six deaths were reported.
  • The monitors on Zoll, Phillips and Physio-Control machines showed error messages on more than 2,000 machines from November 2015 until Feb. 20.
  • From March 16 until Feb. 23, FDA reported 1,680 instances when Physio-Control AEDs failed to power up. No cause could be determined. Since August 2015, nearly 1,200 AEDs made by Physio-Control, Zoll and Philips were classified as “inoperable.”
  • Cardiac Science has had 13 recalls related to its Powerheart models since 2008. One was a model that a police officer unsuccessfully to revive Eugene Malofiy in Southampton, Pennsylvania, in November 2007, according to The Spectrum, journal of the Institute of Electrical and Electronics Engineers. He died.

Bad For Business

A report by Research and Markets predicted that the global market would only average a compounded growth rate of 7.89 percent from 2014 and 2019 because “safety concerns associated with the use of defibrillators are inhibiting the growth of the market.”

“These included patient injuries and deaths caused by the malfunction of devices. As a result of these adverse events, numerous products have been recalled by vendors,” the report said.

This is despite demand that makes some industry analysts believe there is in fact an AED shortage.

There are an estimated 2.4 million AEDs positioned for public access in the United States, when there should be 30 million to cover the country adequately, said Richard Lazar, an AED consultant and member of the Advisory Council of the Sudden Cardiac Arrest Foundation.

“Nobody really knows how many AEDs are out there because manufacturers are really protective of that data,” he said. He estimated annual growth at 9 percent. He said one reason for the shortage can be blamed in part on states that have yet to enact “Good Samaritan” laws protecting people from liability if they use the things.

That hasn’t stopped entrepreneurs and nonprofits from continuing to expand accessibility to AEDs. Entrepreneurs and nonprofits are experimenting with drone technology — particularly in Toronto — to deliver a defibrillator to the scene of a cardiac arrest more quickly than ambulances or defibrillator-equipped police cars.

The nonprofit PulsePoint Foundation has smartphone apps showing the locations of public defibrillators and an Uber-like program in which volunteers respond to cardiac victims with CPR and AEDs. PulsePoint, which has programs in more than 500 U.S. communities, is partnered with Physio-Control. PulsePoint declined comment on Physio-Control's recalls.

Former American Heart Association head Weisfeldt was one of the leading researchers on a major study showing the benefits of public-access defibrillation. He also serves on FDA panels that evaluate and approve the new technology — and take recall action when the machines don’t work.

“You can get 250 reports of (AED’s) misfiring and the company says ‘We don’t know what went on.’ And that’s not acceptable,” he told Benzinga. “The FDA has become much more concerned about faults in AEDs and what you’re seeing in the marketplace (in terms of recalls) is a reflection of the FDA’s concern.”

Analyst Ben Andrew of William Blair & Company noted that most AED pioneers have been absorbed by giant medical device manufacturers. He used to track that sector in the late 1990s, but it’s a futile endeavor now.

“These things have really gone underground, from an investor perspective,” he said.

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Posted In: AEDsAnnals of Emergency MedicineArchives of Internal MedicineAutomated Electronic DebirillatorsBen AndrewdefibrillatorsDiana ZuckermanFrans van HoutenJohns Hopkins Department of MedicineKarl William EdmarkMike WeisfeldtMyron WeisfeldtPulsePoint FoundationStryker Corp.William Blair & CompanyAnalyst ColorBiotechNewsHealth CareFDAExclusivesAnalyst RatingsTechInterviewGeneral

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