Defibtech, LLC just initiated a worldwide voluntary recall of certain DDU-100 series <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall, said the U.S. Food and Drug Administration (FDA) affects only DDU-100 Series AEDs shipped with 2.004 software or earlier.
The FDA has determined that this action is a Class I recall, which means this is a situation in which there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences or death.
The recall has been taken to address two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy, which may, then, result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test.
• Condition 1: In rare instances, the AED may cancel charge in preparation for a shock. Based on field data, the odds of an affected AED having this happen are less than a 1 in 400,000 chance, per month, for any given AED.
• Condition 2: In rare instances, the AED may cancel charge in preparation for a shock in very high humidity conditions. The only reported cases were in environments of greater than 95 percent relative humidity or condensing conditions. Based on field data, the odds of an affected AED having this happen are less than a 1 in 250,000 chance, per month, for any given affected AED.
A subset of AEDs (less than 11 percent) who are affected by Condition 1 are also affected by Condition 2.
Defibtech said it will provide customers with a free software upgrade to address these issues. The correction to the AED will be able to be performed at the location in which the AED is deployed.
Because both of these conditions occur very rarely, it is recommended that customers keep their AEDs in service until they have performed the software upgrade. Full instructions and recommendations are being mailed to affected customers. This customer notification, as well as instructions on determining whether an AED is affected, can also be found on the www.defibtech.com/fa11 web page.
For additional information regarding this recall, consumers are asked to refer to the web page, to contact their distributor, or contact Defibtech at techsupport@defibtech.com, 1.877.453.4507 or 1.203.453.4507.
The AEDs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations.
Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch.
