FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1081043
·
Received July 18, 2008
Report
- Report Number
- 3015876-2008-00812
- Event Type
- Malfunction
- Date Received
- July 18, 2008
- Date of Event
- June 19, 2008
- Report Date
- June 19, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K902288
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER FOR A REPLACEMENT MAIN SYSTEM BOARD. THE REPLACED SYS BOARD WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS INOPERABLE. THERE WAS NO PATIENT 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 |