BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCERTO

    MDR report key: 1912887 · Received November 11, 2010

    Report

    Report Number
    9611530-2010-00111
    Event Type
    Other
    Date Received
    November 11, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY (B)(4), THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION CO IN THE (B)(4).

    Description of Event or Problem · 1

    AS STATED BY THE (B)(6) - "RESIDENT WAS MOVED TO CONCERTO FOR BATHING FROM MAXI MOVE. RESIDENT WAS PLACED ON TROLLEY AND SIDE RAIL WAS NOT FULLY ENGAGED ON LEFT SIDE. LEFT SIDE RAIL WAS NOT LATCHED COMPLETELY AND MATTRESS PAD WAS COVERING THE VIEW OF LATCHES. RESIDENT LEANED AGAINST LEFT SIDE RAIL AND RAIL DROPPED, CAUSING RESIDENT TO SLIDE OFF AND LAND ON THE FLOOR CAUSING INJURY TO SCALP." MANUFACTURER'S REF NO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO LIFT, PATIENT, NON-AC-POWERED FPO ARJO HOSPITAL EQUIPMENT AB BAB1000-04

    Patients

    Seq Age Sex Outcome Treatment
    1