BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINETAMERICAS MULTICARE BED

    MDR report key: 6746454 · Received July 26, 2017

    Report

    Report Number
    MW5071254
    Event Type
    Injury
    Date Received
    July 26, 2017
    Date of Event
    May 10, 2017
    Report Date
    July 17, 2017
    Manufacturer
    LINET
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Description of Event or Problem · 1

    NURSE USED TURN FEATURE ON THE LINET BED TO TURN PATIENT AWAY FROM HER TO ASSESS HIS BACK. THE PATIENT'S WIFE, SITTING IN A WHEELCHAIR ON THE OPPOSITE SIDE OF THE BED, GRABBED THE SIDE RAIL OF THE BED TO HELP STAND UP. THE BED STARTED TO TIP OVER AND THE WHEELS CAME OFF OF THE FLOOR. NURSE RAN TO THE OTHER SIDE OF THE BED TO PUSH THE BED BACK ONTO THE FLOOR. LINET VENDOR/TRAINER CAME TO HOSPITAL TO REVIEW THE EVENT ON (B)(6)2017. WHILE ASSESSING THE TURN FEATURE OF THE BEDS AT THIS HOSPITAL SHE NOTED THAT THEY TURN TO 30 DEGREES. SHE NOTED THAT THE NEW MODEL OF BED LIMIT THE TURN FEATURE TO 15 DEGREES. THIS FACILITY WAS NOT NOTIFIED THAT THE TURN FEATURE ON OUR CURRENT BEDS WAS NOT WITHIN THE SAFE TURNING PARAMETERS. WE REQUESTED FROM LINETAMERICAS IF THE TURN FEATURE COULD BE LIMITED TO 15 DEGREES WITH A SOFTWARE PATCH OR DISABLED. THEY STATED THAT NEITHER COULD BE ACCOMPLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523999 LINETAMERICAS MULTICARE BED LINETAMERICAS MULTICARE BED FNL LINET MULTICARE LE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention