BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 2241357 · Received September 2, 2011

    Report

    Report Number
    1824206-2011-04615
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    HILL-ROM INC
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN REPLACED THE BRAKE DETENT ASSEMBLY TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE BRAKE WILL NOT HOLD DUE TO A BROKEN 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