FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1080092
·
Received July 17, 2008
Report
- Report Number
- 3015876-2008-00808
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 20, 2008
- Report Date
- June 20, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K902288
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HOSP'S BIOMEDICAL ENGINEERING STAFF CONFIRMED THAT THE DEVICE'S POWER SUPPLY WAS REPLACED, RESOLVING THE ISSUE. THE DEVICE WAS PLACED BACK IN SERVICE. THE REPLACED POWER SUPPLY WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVAL. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON AC POWER. THERE WAS NO PT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | PHYSIO-CONTROL, INC. | 9P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |