FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1028046
·
Received April 10, 2008
Report
- Report Number
- 3015876-2008-00309
- Event Type
- Malfunction
- Date Received
- April 10, 2008
- Date of Event
- January 28, 2008
- Report Date
- January 28, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): DEVICE DATA STORAGE, INCLUDING DEFIBRILLATOR CALIBRATION CONSTANTS, ARE STORED IN A BATTERY-BACKED RAM CHIP, DESIGNATOR U28, ON THE MAIN PCB ASSEMBLY. IC CHIP U28 CONTAINS A LITHIUM ENERGY CELL BATTERY THAT CAN MAINTAIN THE DEVICE DATA FOR A MINIMUM OF 5 YEARS CONTINUOUS DUTY. A RECENT FAILURE ANALYSIS HAS DETERMINED THAT A SEVERELY DEPLETED ENERGY CELL CAN RESULT IN A FAILURE OF THE DEFIBRILLATOR TO CHARGE COMPLETELY AND/OR A FAILURE TO DISCHARGE. PHYSIO-CONTROL PROVIDED THE CUSTOMER WITH REPLACEMENT PART NUMBER AND REPAIR INFORMATION.
Description of Event or Problem · 1
FOUND DURING TESTING. THE DEVICE DISPLAYS A SERVICE INDICATOR WHEN POWERING UP AND AN "ENERGY FAULT" WARNING MESSAGE WHEN THE CHARGE BUTTON IS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 9 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |