BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY 3

    MDR report key: 1190555 · Received October 2, 2008

    Report

    Report Number
    1824206-2008-03679
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    HILL-ROM RITTER
    Product Code
    HDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITIES MAINTENANCE INDICATED WHEN THE HI/LOW DOWN SWITCH IS RELEASED, THE HI/LOW FUNCTION WILL RUN UP UNINTENTIONALLY. THE FACILITIES MAINTENANCE REPLACED THE RIGHT SIDERAIL CAREGIVER BOARD TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THE HI/LOW FUNCTION OF THE BED RUNS UP UNINTENTIONALLY.

    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