BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1811404 · Received August 17, 2010

    Report

    Report Number
    1824206-2010-09376
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THE DETENT WAS BROKEN. THE ACCOUNT REPLACED THE BRAKE DETENT ASSEMBLY TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE NEW BRAKE DETENT THE TECHNICIAN INSTALLED ON MOD 424 BROKE AND THE BED WOULD NOT COME OUT OF BRAKE. NO REPORT OF INJURY.

    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