DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

FDA device recall Z-1312-2023 · posted 2023-03-30 · Open, Classified

Recall details

Recalling firm

Defibtech, LLC

Reason for recall

A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

Action taken

Defibtech issued Urgent Medical Device Safety Removal User letter (FA2023-01) on 2/14/23 and 2/17/23 via email to Distributors and End-Users. Letter states reason for recall, health risk and action to take: 1. Confirm receipt of this notice by checking the Read receipt option in the email notification containing this communication. Additionally, complete, sign and return to FA2023@defibtech.com the attached Receipt Letter acknowledging that you have received this recall notification 2. Check the box label s 9-digit serial number of any units in your inventory against the serial numbers listed in the attachment 3. It is requested you quarantine the listed AEDs and Defibtech will contact you to arrange their return to Defibtech for screening 4. If you have further transferred the device to another entity or department, you must provide this notice to affected parties Please return any affected units as identified in the Attachment for replacement. Dedicated support for handling all aspects of the return of identified units will be provided by Defibtech. We will be contacting you shortly to help you with the process and answer any questions. If you have questions now, please feel free to contact us using the email address FA2023@defibtech.com. Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday. To assure that you have received notification of this safety issue and understand your obligation in notifying those in possession of the serial number(s) shipped to you or on your behalf of any required action, please sign and return this letter to A2023@defibtech.com.

Root cause

Device Design

Status

Open, Classified

Product code

MKJ

Quantity affected

29 units

Distribution

US Nationwide distribution.

Date initiated

2023-02-14

Date posted

2023-03-30

Location

Guilford, CT