There are many manufacturers of Automated External Defibrillators (AEDs). Although the units must pass the same rigid FDA tests in order to be marketed to the public, when it comes to recalls, all units are not alike.
AEDs are intended to treat adults and/or children in cardiopulmonary arrest; therefore, the first indication that an AED is faulty could be during an emergency. Subsequent to an AED failing to function as intended, the manufacturer should immediately notify any consumers who could be at risk of their AED malfunctioning and advise them of the procedure to replace and/or repair their AED. The timely fulfillment of this action varies among the manufacturers.
There have been several recalls (click here for the defibrillator recall RSS feed to subscribe), but let’s review a few of the most recent. Looking back over the past year:
When Cardiac Science announced a Voluntary Medical Device Correction action in November 2009 after they received complaints that some AEDs failed to delivery therapy. They sent emails or letters to the customers listed in their data base. Some consumers did not receive any notification from cardiac science for several months.
Cardiac Science required the consumer to log onto their website and enter their serial number to determine if their unit was recalled. The website then informed the consumer if their AED was affected and if so, there would be a correction issued by the manufacturer by May 2010.
The FDA website advised all customers that the AED might fail to perform and they should use a different AED, if available, during an emergency. There are many schools, campuses, police departments, government agencies, etc. that deployed twenty, thirty, fifty or more Cardiac Science AEDs throughout their facilities and ALL of their units were on the affected list.
Cardiac Science is not offering replacement units or loaner units to the consumer stating that the chance of failure is not high enough to warrant such action on their part, and the AEDs should be used. A seven month leeway for correction, no loaners or immediate replacements, and unclear instructions – Cardiac Science needs to improve on their responsibility to their customers.
Physio Control / Medtronic and Philips
All three manufacturers, Medtronic, Physio Control and Philips experienced recalls. These manufacturers notified their customers in a timely and efficient manner, offering immediate replacement and/or upgrades. Their instructions were clear from the initial recall and left no questions to the consumer regarding the procedure during an emergency.
Final Word of advice for the consumer:
No AED brand has more probability of being recalled than another brand. However, if you own an AED, make sure you register your serial numbers with the manufacturer. If there is a recall, you will be sure to receive your notification and you can take the appropriate corrective action as soon as possible.
Denise Mauer is a certified CPR and defibrillator trainer and has more than 10 years experience in the AED industry.