BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 1785811 · Received July 19, 2010

    Report

    Report Number
    9611530-2010-00040
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 8, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): WHILE TRANSFERRING THE RESIDENT INTO THE BATH, A CLIP BROKE ON THE SLING. THE CAREGIVERS WERE ABLE TO BREAK THE PATIENT'S FALL BY CATCHING HIM. NO INJURIES WERE SUSTAINED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KMBB4OLU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR