HeartSine Defibrillator Problems Not Addressed: FDA
HeartSine Technologies, Ltd. has received a warning from federal regulators, after allegedly failing to address specific problems in connection to its defibrillators.
The FDA sent a warning letter on February 3, which outlines the results of an inspection conducted at HeartSign’s Newton, Pennsylvania, factory.
The letter indicates that the company failed to respond to concerns from the inspection within 30 days after receiving notice that the devices may have caused or contributed to a death or serious injury, a reference to several deaths being investigated as part of the Samaritan Public Access Defibrillators (PAD) recall issued in September 2013.
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The inspection was conducted August 13 to August 22, focusing on the recalled Class III Automatic External Defibrillators (AED). The FDA inspectors say HeartSine “failed or refused” to provide necessary information concerning the devices as part of medical device reporting (MDR).
The Samaritan PAD recall was issued due to malfunctions of the Samaritan 300P and Pad Pak. The action was a reissue updating an initial recall from November 2012 for faulty equipment.
That initial class 1 recall came after battery issues prevented users from delivering cardiac therapy to patients during an emergency event. The global recall was then issued in 2013 after the company added new information about an upgrade kit which may be kept near the device.
Class 1 recalls, which are the most serious type of recall, are issued when the affected product may potentially place patients at serious risk for injury or death. At least six deaths may have been associated with HeartSine defibrillator problems.
The warning letter also focused on the company’s failure to adequately develop, maintain and implement medical device reporting (MDR) procedures. The MDR procedures would address necessary documentation of adverse events and determine if an event was reportable, especially concerning a device related injury, malfunction or death.
Procedures that would have been necessary concerning the six deaths which are under investigation in connection to the recall of the defibrillators.
HeartSine was also cited for failing to conduct audits at regular intervals. The warning letter indicates audit information for 2013 was missing during the inspection in August.
The FDA warns failure to comply or correct actions outlined in the warning letter may result in seizure, injunction and civil money penalties for HeartSine.
In March 2013, the FDA proposed new AED guidelines aimed at improving the standards for these devices. The guidelines followed a string of recalls, deaths and other serious problems linked to devices failing when needed to provide a lifesaving jolt.
The FDA was responding to more than 45,000 adverse event reports linked to AEDs. The agency determined that future devices would have to go through premarket approval process, instead of the 510k fast track approval program, allowing the FDA to have a better chance of weeding out faulty devices before they hit the market.
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