BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 1111822 · Received August 14, 2008

    Report

    Report Number
    9611530-2008-00050
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 28, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS AFTER THE RESIDENT WAS LOWERED ON THE TROLLEY AND TURNED ONTO THE SIDE TO BE DRIED, THE STRETCHER OF THE TROLLEY TIPPED. AS THE STRETCHER TIPPED, THE RESIDENT BEGAN TO FALL. TO PREVENT THE RESIDENT FROM FALLING OFF, THE CAREGIVER USED HER BACK TO GUARD THE RESIDENT AND SUPPORT THE STRETCHER. THE CAREGIVER CALLED FOR HELP AND WAS ASSISTED BY ANOTHER CAREGIVER IN REMOVING THE RESIDENT TO SAFETY. AS A RESULT OF THE INCIDENT, ONE OF THE CAREGIVERS INJURED MUSCLES IN THE NECK AND SHOULDER. TREATMENT WAS NOT REQUIRED, BUT TWO DAYS REST WAS GIVEN. THERE WAS NO REPORTED INJURY TO THE RESIDENT. THERE WAS NO REPORT OF ANY ADD'L DEVICE INVOLVED IN THE INCIDENT. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO SHOWER TROLLEY FPO ARJO HOSPITAL EQUIPMENT AB BABXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1