Device product
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Z-2393-2020
Product summary
- Firm
- Defibtech, LLC
- Event
- Event 85702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 860
- Official record key
device-enforcement:Z-2393-2020
Official wording
Reason: A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Code information: Serial Number 400101322
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
Derived failure modes
-
Unknown
A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.