FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1011941
·
Received March 11, 2008
Report
- Report Number
- 3015876-2008-00160
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 11, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K890079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HOSPITAL BIOMEDICAL DEPARTMENT ISOLATED THE ISSUE TO THE HANDS FREE DEFIB ADAPTER. PHYSIO-CONTROL REPLACED THE ADAPTER AND IS CONTINUING TO INVESTIGATE THE REPORTED INCIDENT.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THERE WAS NO QUICK LOOK ECG DISPLAY WHEN ATTEMPTING TO MONITOR PATIENT THROUGH HANDS FREE DEFIB ELECTRODES. NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THE DEVICE USE.
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 | UNK | DEFIBRILLATOR| QUIK-COMBO ADAPTER FOR THE LIFEPAK 10 |