MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-04 for PD1200 DEFIBRILLATOR * manufactured by Zoll Medical Corporation.
[352910]
During regular operational check of defibrillator it was noted that the defibrillator did not work on battery power.
Patient Sequence No: 1, Text Type: D, B5
[21392357]
The model number and the catalog number of the device is: pd1200 defibrillator/pacemaker. During regular operational check of defibrillator it was noted that defibrillator did not work on battery power. The device was able to power on with ac power. "further inspection by biomed confirmed unit would not operate on battery and noted bulging battery pack. Battery was shorted and caused over heating of the assembly. A replacement battery pack was ordered from defib mfr and the battery pack has been saved for eval by vendor. " the mfr of the battery pack was non-zoll and not afilliated with zoll medical. Zoll medical corp contacted the customer to find out if the device was going to be returning for eval. At that time, the customer indicated that the defibrillator is currently operating to specification and the reported problem was attributed to a battery pack mfg by a third party. The complainant has purchased a battery pack from zoll to resolve the reported malfunction. The device will not be returning to zoll for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 549437 |
| MDR Report Key | 549437 |
| Date Received | 2004-10-04 |
| Date of Report | 2004-10-04 |
| Date of Event | 2004-10-03 |
| Report Date | 2004-10-04 |
| Date Reported to FDA | 2004-10-04 |
| Date Added to Maude | 2004-10-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PD1200 DEFIBRILLATOR |
| Generic Name | DEFIBRILLATOR |
| Product Code | LDD |
| Date Received | 2004-10-04 |
| Model Number | PD1200 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 11 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 538927 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 018244105 US |
| Baseline Brand Name | PD1200 DEFIBRILLATOR/PACEMAKER |
| Baseline Generic Name | DEFIBRILLATOR/PACEMAKER |
| Baseline Model No | PD1200 |
| Baseline Catalog No | PD1200 |
| Baseline Device Family | PD1200/D900 |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K873402 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Brand Name | BATTERY PACK |
| Generic Name | DEFIBRILLATOR BATTERY PACK |
| Product Code | MOX |
| Date Received | 2004-10-04 |
| Model Number | B10544 |
| Catalog Number | B10544 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 538928 |
| Manufacturer | UNIPOWER CORPORATION |
| Manufacturer Address | 1216 WEST 96TH STREET MINNEAPOLIS MN 55431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-04 |