MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-05 for HEWLETT PACKARD 43110A NA manufactured by Hewlett-packard Co..
[26668]
On 12/22/93 we were notified by the hospital that the defibrillator failed to function properly on a pt. The hospital also informed us that a second defibrillator was available at the time and used on that pt. We were informed by the hospital that this pt died subsequently but were not made aware of the cause of death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 36861-1994-00002 |
| MDR Report Key | 31919 |
| Date Received | 1994-07-05 |
| Date of Report | 1994-01-07 |
| Date of Event | 1993-12-22 |
| Date Facility Aware | 1993-12-22 |
| Report Date | 1994-01-07 |
| Date Reported to Mfgr | 1994-01-04 |
| Date Added to Maude | 1996-04-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | HEWLETT PACKARD |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1994-07-05 |
| Model Number | 43110A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33063 |
| Manufacturer | HEWLETT-PACKARD CO. |
| Manufacturer Address | CARDIOLOGY BUSINESS UNIT 1700 S. BAKER STREET MCMINNVILLE OR 971289113 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-07-05 |