BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY FOUR BIRTHING BED

    MDR report key: 2923028 · Received December 27, 2012

    Report

    Report Number
    1824206-2012-08584
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SENT ONCE THE CUSTOMER DISCLOSES THEIR INVESTIGATION.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT THE BED EXPERIENCED AN UNINTENTIONAL MOVEMENT OF THE HI/LOW UP FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1