N
Patient 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
MAUDE MDR 8196071
- MDR report key
- 8196071
- Report number
- 1220908-2018-03694
- Event key
- 0
- Event type
- 3
- Date received
- 2018-12-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 269 MILL ROAD CHELMSFORD MA 01824 US
- Phone
- 978-978-9784
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | ZOLL MEDICAL CORPORATION | DPS | MSERIES BI-PHASIC | M SERIES | NA | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-26 | 0 |
Event Narratives#
D
Patient 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
N
Patient 1
ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED BENCH HANDLING AND STRESS TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE ECG CABLE USED DURING THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.