BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE (AHE)

    MDR report key: 1922874 · Received November 12, 2010

    Report

    Report Number
    9611530-2010-00113
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 CO 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 2010 (B)(6): POTENTIAL INCIDENT - LIFT HANGER BAR DETACHED FROM THE HANGER MOUNT DURING A TRANSFER FROM THE WHEELCHAIR TO THE BED ON (B)(6) 2010 AT APPROX 2:25 PM. THE RESIDENT FELL WITH THE HANGER APPROX THREE TO FOUR FEET TO THE FLOOR. THE HANGER ASSEMBLY IS OFF AND BUSHING IS IN PIECES. SCRATCHES ON JIB COVER, LEGS AND BASE. CONNECTIONS FOR PPP BROKEN, LEFT BASE COVER IS ALSO DETACHED, AND RIGHT LEG COVER MISSING. HANGER ASSEMBLY BUSHINGS LIGHTLY WORN. ONE BUSHING IS IN PIECES. THE SLING WAS A GREY CLIP SLING (UNSURE OF MODEL NUMBER). SLING CLIPS WORN. CLOTH IS CLEAN AND IN GOOD CONDITION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE (AHE) LIFT, PATENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KMB*

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR