FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 950038
·
Received November 16, 2007
Report
- Report Number
- 3015876-2007-00478
- Event Type
- Malfunction
- Date Received
- November 16, 2007
- Report Date
- October 19, 2007
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL, INC. INSPECTED THE DEVICE WITH PHYSICAL DAMAGE BEING NOTED TO THE SYSTEM PCB. REPLACEMENT OF THE PCB WAS RECOMMENDED TO THE CUSTOMER; HOWEVER, THE CUSTOMER DECLINED REPAIR AND WILL SCRAP THE DEVICE. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR FURTHER EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON DC POWER. THERE WAS NO PT USE ASSOCIATED WITH 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 YR |