Device product
Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
Z-2565-2014
Product summary
- Firm
- Bio-Detek, Inc.
- Event
- Event 68970
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 cases (300 electordes)
- Official record key
device-enforcement:Z-2565-2014
Official wording
Reason: Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators
Code information: Lot #0413 Expiration Date: 2015-01-26
Distribution pattern: Worldwide Distribution in Germany and Slovenia.
Derived failure modes
-
Unknown
Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators