FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1061764
·
Received June 13, 2008
Report
- Report Number
- 3015876-2008-00602
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 14, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE REQUESTED PART NUMBER AND PRICE FOR REPLACEMENT. THE REPLACED CABLE WILL NOT BE RETURNED TO PHYSIO FOR EVALUATION. ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE DEVICE'S W2 CABLE, BETWEEN THE POWER AND THE THERAPY PCB. THE CUSTOMER CONTACTED PHYSIO-CONTROL TO ORDER A NEW CABLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
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 |