FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1651169
·
Received April 2, 2010
Report
- Report Number
- 3015876-2010-00441
- Event Type
- Malfunction
- Date Received
- April 2, 2010
- Date of Event
- March 3, 2010
- Report Date
- March 3, 2010
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K902288
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): PHYSIO-CONTROL RECOMMENDED THE REPLACEMENT OF THE (B) (4) SMARTWATCH IC U28. THE CUSTOMER'S BIOMED LATER CONFIRMED THAT AFTER REPLACING IC U28 ON THE MAIN PCB, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE UNIT WAS PLACED BACK INTO SERVICE FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING THE SERVICE INDICATOR. AND HAD AN ERROR CODE LOGGED IN MEMORY. IT WAS ALSO INDICATED THAT THE DEVICE WILL POWER ON IN SYNC MODE, AND IT WILL GIVE AN ENERGY FAULT. THERE WAS NO PT USE ASSOCIATED THE REPORTED FAILURE.
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 |