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:
Cardiac Science
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.
Thank you for taking the time to submit this posting. As a certified CPR instructor, I have experienced similar poor communication practices from Cardiac Science. In my opinion Cardiac Science’s salespeople are less than candid in their attempts to close sales opportunities, many times at the cost of delivering misinformation or neglecting to mention the whole story behind their recall history. Additionally, I understand that they have failed to timely report problems and even recalls directly to their clients. One has to wonder if this lack of communication is designed to avoid infringing on revenue generation. For instance, during their July earnings call, Cardiac Science noted that they noticed a recall in the Spring of ’09, budgeted between 10-20 million dollars to handle it, but didn’t announce to their clients their findings until much later in the summer. The problem with any AED recall, is that much more attention is paid by the media and public to the recall than to the public benefits of wide distribution of AED units. Therefore, the problems of one, perhaps less than responsible, organization might detrimentally impact those manufacturers who operate with higher ethical standards.
Thank you for this article and I agree with you guys as an AHA Instructor and having worked with Cardiac Science in the Past their agenda has been market share and more market share in the AED world. Having met some of the sales reps at trade shows they are quite arrogant and with no clinical backround to mention, just glorified “Snake Oil Salemen”. Hey Cardiac Science these end users trusted your sales people in the purchasing process now its time they earn their keep and support your product!!! I remember when they were just a little company out of Irvine, CA nice time to work for them as they were humble then, now its Burdick and Corporate Marching orders to the sales force to meet monthly qoutas… Try CU Medical Systems Inc. I like the IPAD NSF1200
I have a defribilator and I think I don’t need it. I’m always in pain. I have 2 surgerys to repai the defribilator in one week. but I still in pain. I don’t know what to do