BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE (AHE)

    MDR report key: 1971422 · Received January 13, 2011

    Report

    Report Number
    9611530-2011-00003
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

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

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2011-(B)(6): POTENTIAL INCIDENT - PER THE AHUS SERVICE TECH-"RESIDENT WAS IN THE BED AND NEEDED TO BE TRANSFERRED INTO HER WHEEL CHAIR. ONE C.N.A. PLACED THE SLING UNDER THE RESIDENT AND THEN ATTACHED TO THE LIFT. THE RESIDENT WAS THEN RAISED AND MOVED OVER TO THE WHEEL CHAIR. THE POWERED DPS WAS USED TO POSITION THE RESIDENT OVER THE WHEEL CHAIR AND SIT IN A MORE UP RIGHT POSITION. WHEN THE POWERED DPS WAS USED THE C.N.A. HEARD A CLICK AND SAW THE RESIDENT SLIDE DOWN OUT OF THE SLING AND HIT HER HEAD ON THE SEAT PART OF THE WHEEL CHAIR. ONE OF THE LEG CLIPS DETACHED." (B)(4). FUNCTION TEST: LIFT OPERATES UP AND DOWN WITH HANDCONTROLLER AND MEMBRANE SWITCH. THE LEGS OPEN AND CLOSE WITH H/C AND MEMBRANE SWITCH. THE POWER DPS IS ALSO FUNCTIONING CORRECTLY. THE SCALE IS OPERATING CORRECTLY. THE REAR CASTERS BRAKES ARE GOOD. THE FRONT CASTERS ARE WORN, BUT FUNCTIONING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization