FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 136978
·
Received December 4, 1997
Report
- Report Number
- 3015876-1997-00598
- Event Type
- Malfunction
- Date Received
- December 4, 1997
- Date of Event
- November 22, 1997
- Report Date
- December 4, 1997
- Manufacturer
- PHYSIO-CONTROL CORP.
- Product Code
- LDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER | EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR/TRANSCUTANEOUS PAC | LDO | PHYSIO-CONTROL CORP. | 9P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | AND ADAPTER, 11/22/1997| QUIK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES |