N
Patient 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
MAUDE MDR 9540060
- MDR report key
- 9540060
- Report number
- 1220908-2019-04055
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-02
- 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 | DRO | MSERIES BI-PHASIC | M SERIES | NA | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-02 | 0 |
Event Narratives#
D
Patient 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S PACER OUTPUT WAS OUT OF SPECIFICATION. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
N
Patient 1
THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. EVALUATION RESULTS: THE CUSTOMER'S REPORT WAS OBSERVED DURING INITIAL TESTING. HOWEVER, AFTER THE DEVICE WAS DISASSEMBLED TO ISOLATE ROOT CAUSE THE REPORTED PROBLEM COULD NO LONGER BE DUPLICATED. THE BATTERY INTERCONNECT BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.