BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 1912731 · Received November 15, 2010

    Report

    Report Number
    3006697241-2010-00043
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    HILL-ROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND THAT THE ADAPTOR SWITCH HARNESS CABLE FOR THE SAFE VIEW FUNCTION WAS PINCHED AND BARE METAL WIRES WERE VISIBLE. THE TECHNICIAN INDICATED THAT THE HARNESS WAS PINCHED BY A COVER WHICH WAS CAUSED BY AN IMPROPER INSTALLATION WHEN THE BED WAS UPGRADED TO SAFE VIEW. HE UNPLUGGED THE HARNESS AND PATIENT POSITIONING MONITOR AND THE BED NOT DOWN LIGHT FUNCTIONED PROPERLY. THE TECHNICIAN REPLACED THE HARNESS TO REPAIR THE BED.

    Description of Event or Problem · 1

    THE NURSE ALLEGED THE PATIENT POSITIONING MONITOR LIGHT AND BED NOT DOWN LIGHT WERE FLASHING, THIS HAPPENED WHEN THE PATIENT EXITED THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREASSIST BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM DE MEXICO S DE RL DE CV 1170

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK