FDA Adverse Event
Malfunction
Summary report: N
ADVANTA
MDR report key: 1964127
·
Received December 21, 2010
Report
- Report Number
- 1824206-2010-11847
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- December 3, 2010
- Report Date
- December 3, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT STATED THEY FOUND THIS ISSUE OCCURRED WITH EIGHTEEN DIFFERENT ADVANTA BEDS THAT WERE ON THE SAME FLOOR OF THE FACILITY. THE ACCOUNT IS NOT SURE IF THERE WAS SOME TYPE OF SURGE THAT TOOK THE UNIVERSAL TELEVISION BOARDS OUT. THE UNIVERSAL TELEVISION BOARD FAILED. THE ACCOUNT REPLACED THE UNIVERSAL TELEVISION BOARD IN ALL EIGHTEEN BEDS TO RESOLVE THE ISSUE. THE ACCOUNT DID NOT HAVE THE SERIAL NUMBERS FOR THE BEDS.
Description of Event or Problem · 1
ACCOUNT ALLEGED THAT THEY ARE JUST NOW HOOKING BEDS UP TO THE NURSE CALL IN ORDER TO SEND PRIORITY CALL WHEN PPM IS ALARMING. ACCOUNT STATED THEY HAVE FOUND MULTIPLE BEDS NOT SENDING CALLS WHEN ALARMING BUT DO ALARM LOCALLY AT THE BED. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTA | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |