BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTICARE

    MDR report key: 6054067 · Received October 25, 2016

    Report

    Report Number
    6054067
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 19, 2016
    Manufacturer
    LINET AMERICAS
    Product Code
    INY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S BED FROZE WHILE THE PATIENT WAS IN ROTATION MODE AT 15 DEGREES. THE PATIENT WAS A CRITICALLY ILL PATIENT IN ARDS THAT REQUIRED ROTATION FOR HER ILLNESS. WE TRIED EVERYTHING TO FIX THE BED SUCH AS TURNING IT OFF, UNPLUGGING IT, PUSHING EVERY BUTTON ETC. ERROR CODE 4 AND 13 APPEARED ON THE SCREEN. WE HAD TO MOVE THE PATIENT TO A NEW BED WITH HER AT 15 DEGREES. THIS NOT ONLY WAS POTENTIALLY DANGEROUS FOR THE PATIENT BUT IT COULD HAVE CAUSED HARM TO OUR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705813 MULTICARE BED, PATIENT ROTATION, MANUAL INY LINET AMERICAS 56011347B-02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO