Beaverton, Ore.-based Welch Allyn and the U.S. Food and Drug Administration have issued a recall of some 14,000 external defibrillators, saying the devices may produce low-energy shocks or be susceptible to unexpected shutdowns or electromagnetic interference, the Associated Press reports.
In a statement, the company cited 39 reported incidents, including two that involved patient deaths, with 14,054 AED 10 and MRL JumpStart external defibrillators made between Oct. 3, 2002, and Jan. 25, 2007, that might prevent defibrillation of a patient in cardiac arrest. Spokesman Jamie Arnold told the AP, however, that to the company's knowledge, the reported defects did not contribute to the two deaths, but rather were the result of human error, either damage to the device or failure to follow directions.
The company issued the recall last Tuesday after it said it had received 20 reports of low-energy shock, eight instances of electromagnetic noise interference, and 11 instances of unexpected device shutting down, the AP reported. The company said customers should keep using the units until they receive replacements, because the chance of malfunction is low, the wire service said. Defibrillators deliver an electric shock to prevent sudden death when a heart stops beating properly.