FDA Adverse Event
Malfunction
Summary report: N
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIB
MDR report key: 2211990
·
Received July 8, 2011
Report
- Report Number
- 3015876-2011-00518
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE. F/U WITH THE REPORTER FOUND THAT THE CUSTOMER IS CONSIDERING PURCHASING A REPLACEMENT DEFIBRILLATOR INSTEAD OF REPAIR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DISPLAYED THE FLASHING WRENCH AND LOGGED AN EVENT CODE THAT INDICATED A POSSIBLE CRITICAL FAILURE. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIB | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |