BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 2222439 · Received July 14, 2011

    Report

    Report Number
    1824206-2011-03738
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNTS BIOMED STATED THE HEAD SECTION WILL NOT GO DOWN ELECTRICALLY, BUT WHEN IT IS TAKEN DOWN USING THE CPR, IT WILL GO RIGHT BACK UP UNINTENTIONALLY.

    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