Device product
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Z-0658-2013
Product summary
- Event
- Event 62950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3881 in US, 1846 ROW.
- Official record key
device-enforcement:Z-0658-2013
Official wording
Reason: Complaints associated with an unexpected stop in AutoPulse compressions.
Code information: all
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Complaints associated with an unexpected stop in AutoPulse compressions.