Welch Allyn Recalls Automatic External DefibrillatorsMar 17, 2009 | Parker Waichman LLP
Welch Allyn has issued a worldwide recall of various AED 10 and MRL JumpStart automatic external defibrillators manufactured between October 3, 2002 and January 25, 2007. The Food & Drug Administration (FDA) has deemed the Welch Allyn defibrillator recall a Class I recall because there is a reasonable probability that use of the product will cause serious injury or death.
According to the FDA, the recalled Welch Allyn defibrillators are used by emergency or medical personnel, or by others who have completed CPR AED training courses. The devices are intended to treat adults who are having a heart attack. The device analyzes an unconscious patient’s heart rhythm and automatically delivers an electrical shock to the heart if needed to restore a normal heart rhythm.
According to the Welch Allyn website, the recalled defibrillators could have one or more of the following defects:
- Low Energy Shock
- Electromagnetic Noise Interference
- Unexpected Shutdown During Use
- Blown Fuse
- Loss of Voice Prompts
- Shutdown in Cold Temperatures
Welch Allyn is warning that these issues could lead to a sudden stoppage of the device, and may prevent defibrillation of a patient in cardiac arrest, which could lead to death. There have been 20 reported instances of low energy shock, 8 of electromagnetic noise interference, and 11 of unexpected device shutdown, according to a Welch Allyn press release.
The company sent a recall notification letter to distributors and customers on February 26-27, 2009. Welch Allyn customers in the U.S. and Canada may (1) at no cost, exchange their Welch Allyn AED 10 for a like device, or (2) purchase a new AED 10 directly from Welch Allyn, with a standard 5-year warranty, at a significantly reduced cost. All international customers will be offered exchange AED 10 devices.
Customers are being told to keep AED 10 or MRL JumpStart units in use until they receive replacements. If a unit gives a low energy shock warning during use, consumers should keep using the device in accordance with its voice prompts and directions for use. A low energy shock may still be clinically effective, and a full energy shock can follow a low energy shock.
Customers may visit the Welch Allyn Website for more information or to learn if their unit is subject to this recall.