BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI 500

    MDR report key: 2862274 · Received November 29, 2012

    Report

    Report Number
    9681684-2012-00088
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 31, 2012
    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 ARJOHUNTLEIGH ON BEHALF OF THE MFR ARJOHUNTLEIGH (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. THE LIFT IS IN GOOD WORKING ORDER. THE SAFETY CLIPS ARE IN POSITION ON THE EACH HOOK OF THE 2-POINT SPREADER BAR. THE SLING IS AN OLDER SLING AND SHOULD BE REPLACED. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    A SINGLE STAFF MEMBER PREPARED THE RESIDENT FOR A TRANSFER FROM BED TO TOILET WITH A FLOOR LIFT AND A LOOP SLING. SHE WAS WAITING FOR THE SECOND STAFF MEMBER BUT STARTED TO LIFT THE RESIDENT BY HERSELF. AS THE STAFF MEMBER STARTED TO MOVE THE DEVICE, THE RIGHT SHOULDER STRAP OF THE SLING SLIPPED OFF THE 2-POINT HANGER BAR, MAKING THE RESIDENT LEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI 500 MANUFACTURED FLOOR PASSIVE LIFT FNG ARJOHUNTLEIGH MAGOG INC. KM560001

    Patients

    Seq Age Sex Outcome Treatment
    1