ISSUE
: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
BACKGROUND
: AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
RECOMMENDATION
: Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Class I Recall, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm254929.htm