BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 1982398 · Received January 14, 2011

    Report

    Report Number
    9615739-2011-00007
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    HILL-ROM INDUSTRIES S.A.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE CASTERS AT THE FOOT END OF THE BED NOT HOLDING AND WERE RATCHETING. HE ATTEMPTED TO ADJUST THE CASTERS FIRST, BUT FOUND THE BRAKE ON THE CASTER WAS WORN. THE CUSTOMER IS CONSTANTLY PLACING THE BRAKE ON/OFF AND MOVING THE BED FROM THE FOOT END TO PLACE THE PATIENT IN AND OUT OF BED. THE TECHNICIAN REPLACED THE CASTERS ON THE FOOT END OF THE BED TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED WHEN THE BRAKES ARE SET ON THE BED, THE BRAKES ARE NOT HOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREASSIST BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INDUSTRIES S.A. 1170

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK