Device product
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
Z-1669-2013
Product summary
- Event
- Event 65462
- Status
- Terminated
- Classification
- Class II
- Quantity
- 657 units
- Official record key
device-enforcement:Z-1669-2013
Official wording
Reason: Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
Code information: 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.