Defibtech issues Class 1 recall of 5,418 AED battery packs
Defibtech has issued a voluntary recall for 5,418 DBP-2800 battery packs used in its Lifeline AED and ReviveR AED external defibrillators because of reports that the devices have not delivered shock therapy due to the report of false errors during a charge.
According to the Guilford, Conn.-based company, the recall pertains to all DBP-2800 units shipped before June 4, 2007, after the company received reports from four patients who said the device malfunctioned during use.
Defibtech said that it has mailed a copy of recommendations for users to follow until the problem has been corrected. These recommendations allow the device to remain in service. The outlined recommendations are here.
The company said that users will be provided with a free battery pack update card and can be updated at the location where the device is used using any DDU-100 series AED and the supplied update card. The company reported that the update is expected within the next two weeks.
The FDA has classified the recall as Class I and asks users who experience adverse reactions to report problems to the MedWatch program.
According to the Guilford, Conn.-based company, the recall pertains to all DBP-2800 units shipped before June 4, 2007, after the company received reports from four patients who said the device malfunctioned during use.
Defibtech said that it has mailed a copy of recommendations for users to follow until the problem has been corrected. These recommendations allow the device to remain in service. The outlined recommendations are here.
The company said that users will be provided with a free battery pack update card and can be updated at the location where the device is used using any DDU-100 series AED and the supplied update card. The company reported that the update is expected within the next two weeks.
The FDA has classified the recall as Class I and asks users who experience adverse reactions to report problems to the MedWatch program.