FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1012852
·
Received March 12, 2008
Report
- Report Number
- 3015876-2008-00168
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 13, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K955854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTER DECLINED AN OFFER OF SERVICE FROM PHYSIO-CONTROL. PHYSIO PROVIDED DESCRIPTION OF LOGGED FAULT CODE AND CORRECTIVE ACTION RELATED TO FAULT. THIS INFORMATION IS LOCATED IN THE DEVICE SERVICE MANUAL.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, A THIRD PARTY BIOMEDICAL TECHNICIAN SERVICING A CUSTOMER'S DEVICE, THE DEVICE ILLUMINATES A FLASHING SERVICE WRENCH AND LOGGED FAULT CODE RELATING TO THE BOOT-UP SELFTEST. THERE WAS NOT PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |