FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 11 DEFIBRILLATOR/PACEMAKER
MDR report key: 1172733
·
Received September 22, 2008
Report
- Report Number
- 3015876-2008-01233
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 23, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- DRO
- PMA / PMN Number
- K951593
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED AN INTERMITTENT "THERAPY LEADS OFF" MESSAGE. PHYSIO REPLACED THE THERAPY CABLE MODULE AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, IN A DAILY TEST, THE DEVICE ALARMED THAT THE THERAPY CONNECTOR WAS NOT CONNECTED. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 11 DEFIBRILLATOR/PACEMAKER | DRO | PHYSIO-CONTROL, INC. | 11 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |