Device product
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Z-1185-2013
Product summary
- Firm
- Covidien LLC
- Event
- Event 64868
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7485 (sets of 2)
- Official record key
device-enforcement:Z-1185-2013
Official wording
Reason: Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Code information: Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
Derived failure modes
-
Unknown
Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient