BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMOVE

    MDR report key: 1882838 · Received October 15, 2010

    Report

    Report Number
    9611530-2010-00078
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE (B)(6) 2010. THE RESIDENT WAS BEING TRANSFERRED FROM A CHAIR TO A BED WHEN THE LEFT LEG SLING CLIP DETACHED FROM THE LIFTER. THE RESIDENT HAD JUST MOVED AWAY FROM THE CHAIR WHEN THEY SLID THROUGH THE OPENING AND ONTO THE FLOOR. THE RESIDENT SUFFERED BRUISING ON HIS SHOULDERS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KRA0300

    Patients

    Seq Age Sex Outcome Treatment
    1