BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1062750 · Received June 18, 2008

    Report

    Report Number
    1824206-2008-02706
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY FOUND THE RELAY FOR THE HEAD SECTION CAUSED THE UNINTENTIONAL ACTIVATION. THE FACILITY REPLACED THE RELAY TO REPAIR THE BED.

    Description of Event or Problem · 1

    ALLEGED THE HEAD SECTION OF THE BED WILL RUN UP ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY 3 BIRTHING BED HDD HILL-ROM RITTER 3700

    Patients

    Seq Age Sex Outcome Treatment
    1