FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBIRLLATOR/MONITOR
MDR report key: 1051171
·
Received May 22, 2008
Report
- Report Number
- 3015876-2008-00528
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 22, 2008
- Report Date
- April 22, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- 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 PART NUMBER FOR A REPLACEMENT PADDLE SET. THE CUSTOMER LATER CONFIRMED THAT THE PARTS HAVE BEEN ORDERED TO REPAIR THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CHARGE BUTTON ON THE DEVICE STANDARD PADDLES WAS MISSING. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBIRLLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |