BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 1061488 · Received June 16, 2008

    Report

    Report Number
    9611530-2008-00037
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE CAREGIVER WAS ATTEMPTING TO TRANSFER THE RESIDENT TO THE SHOWER ROOM. DURING THE TRANSPORT, THE BOLTS SHEARED OFF, CAUSING THE STRETCHER TO FLIP OVER, ALLOWING THE RESIDENT TO FALL TO THE FLOOR. THE RESIDENT WAS SENT TO THE HOSPITAL WITH MULTIPLE BRUISES. THE RESIDENT WAS STILL AT THE HOSPITAL AT THE TIME OF INTERVIEW WITH FACILITY PERSONNEL.

    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 Hospitalization