BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1891352 · Received November 2, 2010

    Report

    Report Number
    1824206-2010-10831
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    HILL-ROM INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BRAKE DETENT MECHANISM WAS REPLACED TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE BRAKE IS NOT LOCKING DUE TO A CRACKED BRAKE DETENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 4 BIRTHING BED HDD HILL-ROM INC. 3700B

    Patients

    Seq Age Sex Outcome Treatment
    1