BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 2253849 · Received August 11, 2011

    Report

    Report Number
    1824206-2011-04251
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    HILL-ROM, INC.
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPAIRS HAVE NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNTS MAINTENANCE STATED THE BRAKE IS NOT HOLDING.

    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