FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 326306
·
Received April 4, 2001
Report
- Report Number
- 3015876-2001-00159
- Event Type
- Malfunction
- Date Received
- April 4, 2001
- Report Date
- March 6, 2001
- Manufacturer
- MEDTRONIC PHYSIO-CONTROL CORP.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE WAS REPORTEDLY USED ON A PT DURING A STORM WITH 40 MPH WIND GUSTS THAT ALLEGEDLY REPEATEDLY TRIGGERED THE DEVICE'S MOTION DETECT CIRCUITRY WHEN ECG ANALYSES WERE ATTEMPTED. A BACK UP MANUAL DEFIBRILLATOR WAS OBTAINED AND TREATMENT WAS CONTINUED USING THE MANUAL DEFIBRILLATOR. THE PT WAS TRANSPORTED TO A LOCAL HOSP AND DIED AT THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14720 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR | MKJ | MEDTRONIC PHYSIO-CONTROL CORP. | 500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |