FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1001105
·
Received February 14, 2008
Report
- Report Number
- 3015876-2008-00058
- Event Type
- Malfunction
- Date Received
- February 14, 2008
- Date of Event
- January 16, 2008
- Report Date
- January 16, 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 RECOMMENDED REPLACING ADAPTER AND PROVIDED CUSTOMER WITH PART NUMBER, PRICE, AND AVAILABILITY. PROCESS CHANGES TO INCREASE THE AMOUNT OF ADHESIVE TO THE ELECTRODE PLATE HAVE BEEN IMPLEMENTED.
Description of Event or Problem · 1
FOUND DURING INSPECTION. ACCORDING TO THE REPORTER, AN ELECTRODE PLATE FROM THE ADULT PADDLE ADAPTER IS LOOSE AND NOT TOUCHING ITS CONTACT IN THE PADDLE HANDLE. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED INCIDENT.
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 | NA |