BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI TWIN

    MDR report key: 2223469 · Received June 20, 2011

    Report

    Report Number
    9611530-2011-00049
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    DUE TO A TECHNICAL FAILURE OF THE DEVICE, THE LEGS COULD BE MOVED TO THE SAME POSITION. THE RESULT WAS THAT THE PT WAS OUT OF LIFT TRANSFER AREA (SUPPORT AREA) AND FELL. THE TABLE AND THE CAREGIVER CAUGHT THE PT AND LET HIM DOWN TO THE FLOOR; THE CAREGIVER SUFFERED FROM A SORE NECK DUE TO THE ASSISTANCE THEY GAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI TWIN PASSIVE FLOOR LIFT FSA ARJO HOSPITAL EQUIPMENT AB KTBB4BSX2EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other