FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1082784
·
Received July 24, 2008
Report
- Report Number
- 3015876-2008-00834
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 26, 2008
- Report Date
- June 26, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K973486
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED PARTS INFORMATION TO CUSTOMER FOR REPLACEMENT.
Description of Event or Problem · 1
CUSTOMER STATED THEY NEEDED THE PART NUMBER FOR DEVICE'S STANDARD PADDLES. THEY STATED THAT THE PADDLES HAD WORN. THERE WAS NO PT USE ASSOCIATED WITH THE REPORT.
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 |