BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA

    MDR report key: 1964177 · Received December 21, 2010

    Report

    Report Number
    1824206-2010-11870
    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 ALL ON THE SAME FLOOR OF THEIR 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 A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1600

    Patients

    Seq Age Sex Outcome Treatment
    1