FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1170339
·
Received September 11, 2008
Report
- Report Number
- 3015876-2008-01092
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 10, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DISPLAYED A "CANNOT CHARGE" WARNING MESSAGE WHEN THE HOSPITAL STAFF PRESSED THE CHARGE BUTTON WHILE ATTEMPTING TO ADMINISTER A SYNCHRONIZED SHOCK TO A PATIENT WITH AN SVT ARRHYTHMIA. ANOTHER DEVICE WAS USED TO TREAT THE PATIENT. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT REPORTED 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 |