FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1070730
·
Received July 2, 2008
Report
- Report Number
- 3015876-2008-00738
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 3, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K890079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL INFORMED CUSTOMER THAT THIS DEVICE PROBABLY NEEDS REPLACEMENT. THE HOSPITAL'S BIOMEDICAL ENGINEER COMMENTED THAT THEY WERE HOPING TO GET THIS DEVICE RETIRED, AND WAS GOING TO DECIDE IF WANTED TO REPAIR. THE CUSTOMER HAS NOT YET CONFIRMED WITH PHYSIO-CONTROL THEIR DECISION REGARDING THIS DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING SEVERAL ERRORS, INCLUDING LOCKED-UP CODES. THERE WAS NO PT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | PHYSIO-CONTROL, INC. | 10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |