BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BED

    MDR report key: 1156124 · Received September 8, 2008

    Report

    Report Number
    1824206-2008-03315
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITIES ENGINEER MADE AN UNSUCCESSFUL ATTEMPT TO ADJUST THE BRAKE CASTERS. THE ENGINEER ORDERED NEW CASTERS FOR THE REPAIR OF THE BED. FOLLOW-UP CALLS MADE BY HILL-ROM WERE NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGED THE BRAKE CASTERS WILL SWIVEL WHEN LOCKED INTO BRAKE. PURSUANT TO OUR RESPONSE TO WARNING LETTER, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY BED BIRTHING BED HDD HILL-ROM RITTER 3600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK