BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI 500

    MDR report key: 2862273 · Received November 29, 2012

    Report

    Report Number
    9681684-2012-00094
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED FROM HIS BED TO A WHEELCHAIR WITH A FLOOR LIFT, POSITIONED ON THE SIDE OF THE WHEELCHAIR. THE RESIDENT WAS STARTING TO GET LOWERED INTO WHEELCHAIR. WHEN THE RESIDENT WAS CLOSE TO BEING INTO THE WHEELCHAIR, THE WHEELCHAIR STARTED TO TIP FORWARD AND THE LIFT WAS STARTING TO DO TO THE LEFT. THE STAFFS CALLED FOR EXTRA HELP AND WERE ABLE TO LOWER RESIDENT TO FLOOR. AFTER RESIDENT WAS LOWERED TO THE FLOOR, THE DEVICE WAS REMOVED FROM LIFT AND THEN FOUR PEOPLE HELPED RESIDENT BACK INTO BED. A CAREGIVER SUSTAINED BRUISES TO RIGHT SHOULDER AND SORENESS TO LOWER BACK, AND HAD PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI 500 MANUFACTURED FLOOR PASSIVE LIFT FSA ARJOHUNTLEIGH MAGOG INC. KM560181

    Patients

    Seq Age Sex Outcome Treatment
    1