BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 4

    MDR report key: 1250891 · Received December 2, 2008

    Report

    Report Number
    1824206-2008-04443
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE HEAD SECTION RAN UP UNINTENTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 4 BIRTHING BED HDD HILL-ROM RITTER 3700B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK