FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1983194
·
Received February 2, 2011
Report
- Report Number
- 3015876-2011-00101
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 7, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K955854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO RECOMMENDED SYSTEM PCB REPLACEMENT TO TROUBLE SHOOT THE ISSUE/REPAIR THE DEVICE. HOWEVER, THE CUSTOMER DECLINED PHYSIO'S REPAIR OFFER AND ELECTED TO PURCHASE A REPLACEMENT DEFIBRILLATOR INSTEAD. HENCE, A CONCLUSIVE CAUSE OF THE FAILURE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY FAILED TO POWER ON. THE DEVICE INTERMITTENTLY FAILED TO RECOGNIZE THE INSTALLED BATTERY OR SHOWED A FALSE LOW BATTERY INDICATION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE 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 |