BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMANUFACTURED TOTAL CARE

    MDR report key: 1851991 · Received September 24, 2010

    Report

    Report Number
    1824206-2010-10110
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT FOUND THAT THE F2 FUSE WAS BLOWN. ACCOUNT REPLACED THE FUSE AND ALLEGED THAT THE F10 FUSE IS NOW POPPING. ACCOUNT ISOLATED THE HAND CONTROL PENDANT AND VERIFIED THIS WAS CAUSING THE FUSES TO EXPIRE. THERE WAS A SMALL CUT ON THE PENDANT CABLE THAT THEY BELIEVE WAS CAUSING THE ISSUE. NO EXPOSED WIRES BUT THE SHIELDING COULD BE SEEN IN THE DAMAGED AREA. ACCOUNT REPLACED THE PENDANT. ACCOUNT STATED THAT THEY NOW HAVE 30-35,36 CODE COMING UP. ACCOUNT STATED THAT THEY REPLACED THE LEFT USER CONTROL MODULE CABLE TO RESOLVE THE LAST ISSUE.

    Description of Event or Problem · 1

    ACCOUNT STATED THIS BED WAS IN THE LOWEST HI/LOW POSITION AND IT HAD NO POWER. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMANUFACTURED TOTAL CARE A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. PR1900

    Patients

    Seq Age Sex Outcome Treatment
    1