FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1071851
·
Received July 8, 2008
Report
- Report Number
- 3015876-2008-00774
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- June 17, 2008
- Report Date
- June 17, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED PARTS INFORMATION TO CUSTOMER FOR REPAIR.
Description of Event or Problem · 1
CUSTOMER CALLED FOR PARTS INFORMATION FOR REPLACING THERAPY CONNECTOR. CUSTOMER REPORTED THAT A LOW VOLTAGE PIN BROKE OFF FROM A STANDARD PADDLES ASSEMBLY AND CANNOT BE REMOVED FROM CONNECTOR. NO PATIENT WAS ASSOCIATED WITH THE REPORTED INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |