FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1033504
·
Received April 23, 2008
Report
- Report Number
- 3015876-2008-00387
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 22, 2008
- Report Date
- March 27, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K955854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED INCIDENT.
Description of Event or Problem · 1
FF/EMT'S RESPONDED TO A PERSON DOWN FOR AN UNKNOWN PERIOD OF TIME. THE DEVICE WAS CONNECTED TO THE PT BUT, ACCORDING TO THE REPORTER, CONTINUOUSLY ALARMED "CONNECT ELECTRODES" AND WOULD NOT ANALYZE THE PATIENT'S RHYTHM. SOME MOMENTS LATER, AN ALS CREW ARRIVED AND TOOK COMMAND OF THE SCENE. THE PT WAS NOT RESUSCITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | ECG ELECTRODES| P/N & D/C UNK| KIMBERLY-CLARK DISPOSABLE DEFIBRILLATION |