FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1033058
·
Received April 23, 2008
Report
- Report Number
- 3015876-2008-00372
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE THERAPY CONNECTOR WAS LOOSE WHEN CONNECTED TO A THERAPY CABLE. PHYSIO REPLACED THE THERAPY CONNECTOR AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT DEVICE'S CABLE CONNECTOR HAS INTERMITTENT CONNECTION TO THERAPY CONNECTOR AND DEVICE OPERATION GOES BACK AND FORTH BETWEEN "CONNECT CABLE" AND "ANALYZING" PROMPTS. THERE WERE NO REPORTS OF ANY ADVERSE AFFECTS AS A RESULT OF DEVICE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |