BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 600

    MDR report key: 2935875 · Received January 22, 2013

    Report

    Report Number
    9681684-2013-00008
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE 2 NURSING STAFF MEMBERS WERE TRANSFERRING A PT FROM HIS WHEELCHAIR TO HIS BED WITH A CEILING LIFT AND A CLIP SLING, THE LEFT LEG CLIP GAVE WAY AND THE CLIENT SLIPPED INTO HIS CHAIR. THE PT WAS NO INJURED AS THEY WERE ABOVE THE CHAIR ONLY A FEW INCHES WHEN IT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31477 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FNG ARJOHUNTLEIGH MAGOG INC LD10009

    Patients

    Seq Age Sex Outcome Treatment
    1