FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1070821
·
Received July 3, 2008
Report
- Report Number
- 3015876-2008-00752
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 6, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER AND ORDERING INFO FOR A REPLACEMENT MAIN PCB. THE CUSTOMER LATER CONFIRMED THAT THE MAIN PCB ASSEMBLY WAS REPLACED, RESTORING PROPER DEVICE OPERATION. THE DEVICE WAS RETURNED TO SERVICE. THE REPLACED ASSEMBLY 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 THAT THE DEVICE HAD AN ENERGY FAULT ERROR CODE. THE CUSTOMER STATED THAT THE DEVICE WOULD NOT BE CAPABLE OF DELIVERING ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
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 |