BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 1 & 2

    MDR report key: 1843756 · Received September 21, 2010

    Report

    Report Number
    1824206-2010-10036
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    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

    TECH FOUND THAT THE CASTERS WERE WORN. TECH REPLACED THE CASTERS AND THE BRAKES FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    TECH ALLEGED THAT WHEN THE BRAKES WERE ENGAGED, THE CASTERS DID NOT HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 1 & 2 BIRTHING BED HDD HILL-ROM INC. P3600E

    Patients

    Seq Age Sex Outcome Treatment
    1