FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1120063
·
Received August 15, 2008
Report
- Report Number
- 3015876-2008-00955
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- March 31, 2008
- Report Date
- March 31, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K890079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER FOR A REPLACEMENT ENERGY SELECT KNOB, RETAINER, AND LABEL. THE DEVICE WILL NOT BE EVALUATED BY PHYSIO-CONTROL. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE'S STERNUM PADDLE ENERGY SELECT KNOB WAS BROKEN. THERE WERE NO REPORTS OF 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 |