Medical Device Daily Washington Editor
WASHINGTON – HeartSine Technologies (San Clemente, California) issued a recall for certain models in its Samaritan line of automated external defibrillators (AEDs).
George Brdlik, director of quality assurance and regulatory affairs for HeartSine, told Medical Device Daily the recall was prompted by several user reports that the AED would announce a fault warning and shut down during a charge attempt, which could result in a treatment delay or even the death of a patient.
In some cases, the device would recharge and function normally, he said. At other times, the AED would shut down again before being able to deliver its lifesaving shock.
Brdlik said the company had one report involving a patient who was resuscitated safely following the incident and that "three or four" other reports of malfunction were the result of routine testing with defibrillator analyzers.
No injuries have been reported so far.
The Samaritan models involved in the recall are SAM-001, SAM-002 and SAM-003, with serial numbers within the range of 1270-2324, the company said. Brdlik said HeartSine has notified its distributors and customers with a letter sent out last month. To resolve the problem, the company is providing a user-installable software upgrade kit for affected units.
"Most customers have already received the upgrade kits, and it is very easy to install," Brdlik said, with 30 to 40 customers left to be supplied.
The new software upgrades now are part of the company's standard production models.
A total of 672 of the affected Samaritan AEDs have been distributed worldwide, including 532 in the U.S.
"Everyone we have contacted about it has been pretty matter-of-fact about it," he said. "There haven't been any calls of significant concern from the field."
Brdlik said it was too early to tell whether the recall would affect sales of the devices, but did not expect that it would.
The FDA classified the event as a Class I recall, which involves situations where there is a reasonable probability that use of the affected product could lead to serious injury or death if the problem is not corrected.
HeartSine's SAM-300 model AED is not part of the recall.