MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-12-04 for LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER 805460-16 manufactured by Physio-control Corp..
[75295]
Emergency department personnel responded to a person diagnosed as in atrial fibrillation. The device was connected to the patient with pacing/defibrillation/ecg electrodes and adapter. According to the reporter, when the patient was countershocked, the device did not cardiovert the patient. The reporter stated that when the electrodes were removed, the device's standard paddles used and a countershock delivered at the same energy, the patient was cardioverted. The patient was resuscitated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3015876-1997-00598 |
| MDR Report Key | 136978 |
| Report Source | 01,07 |
| Date Received | 1997-12-04 |
| Date of Report | 1997-12-04 |
| Date of Event | 1997-11-22 |
| Report Date | 1997-11-24 |
| Date Mfgr Received | 1997-11-24 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1997-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER |
| Generic Name | EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR/TRANSCUTANEOUS PAC |
| Product Code | LDO |
| Date Received | 1997-12-04 |
| Returned To Mfg | 1997-11-25 |
| Model Number | 9P |
| Catalog Number | 805460-16 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 133803 |
| Manufacturer | PHYSIO-CONTROL CORP. |
| Manufacturer Address | 11811 WILLOWS RD., N.E. REDMOND WA 980521013 US |
| Baseline Brand Name | LIFEPAK 9B DEFIBRILLATOR/MONITOR/PACEMAKER |
| Baseline Generic Name | EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR/TRANSCUTANEOUS PAC |
| Baseline Model No | 9P |
| Baseline Catalog No | 805460-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-12-04 |