BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY BIRTHING BED

    MDR report key: 2942329 · Received January 8, 2013

    Report

    Report Number
    1824206-2013-00186
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE BRAKE CAM PIVOT AND DETENT ASSEMBLY ARE CRACKED. THE TECHNICIAN REPLACED THE BRAKE CAM PIVOT AND THE BRAKE DETENT ASSEMBLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED THAT THE BRAKES CASTERS ARE NOT HOLDING. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10365 AFFINITY BIRTHING BED BIRTHING BED HDD HILL-ROM, INC. 3600

    Patients

    Seq Age Sex Outcome Treatment
    1