MalfunctionKRF
M SERIES
Received Dec 5, 2000
Report 1220908-2000-01294 · MDR key 308375
Device
Generic name
Defibrillator/pacemaker
Manufacturer
Zoll Medical CorporationModel number
MSERIESCatalog number
M SERIES
Lot number
NA
Product problems
- Failure to Discharge
- Failure to Analyze Signal
Patient
NA
Narrative
Description of Event or Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK OF THE DEVICE BY A CLINICIAN, THE "ANALYZE" DID NOT FUNCTION. THE CLINICIAN THEN PUT THE DEVICE INTO MANUAL MODE AND CHARGED THE DEVICE, BUT WHEN THEY ATTEMPTED TO DISCHARGE THE ENERGY, THE DEVICE WOULD NOT DISCHARGE INTO THE SIMULATOR. THE COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.