BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 2110528 · Received May 26, 2011

    Report

    Report Number
    9611530-2011-00045
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SLING IN QUESTION WAS NOT EVALUATED BY THE SERVICE TECH AS THE FACILITY DID NOT QUARANTINE IT FOR EVAL (THE INCIDENT OCCURRED A MONTH PRIOR TO NOTIFYING ARJOHUNTLEIGH, AND THE FACILITY HAD USED THE LIFT AND THE SLING SINCE). WHILE THE FACILITY STATES THAT THE SLING CLIPS DETACH EASILY, OUR TECH WAS NOT ABLE TO CONFIRM THIS SINCE THE SLING IN QUESTION WAS NOT LOCATED, NOR WAS THE AGE OF THE SLING ABLE TO BE CONFIRMED. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    PER THE ARJOHUNTLEIGH SERVICE TECH: "DURING A TRANSFER FROM THE CARENDO TO THE BED, THE PT COMPLAINED OF PAIN IN HER LEG. THE PT HAD BEEN RAISED TO ABOVE BED LEVEL BUT NOT MOVED OVER THE BED WHEN THE AIDES ATTEMPTED TO RE-POSITION THE PT IN THE SLING TO RELIEVE THE PAIN. THE PT HAD HER RIGHT HAND ON THE HANGER BAR WHILE BEING RE-POSITIONED AND LET GO WHEN REQUESTED. AT THIS TIME, THE RIGHT SHOULDER SLING CLIP BECAME DISCONNECTED FROM THE HANGER BAR, RESULTING IN THE BACK OF HER HEAD HITTING SOMETHING (UNK) CAUSING THE LACERATION. AIDES STATE THAT THIS SLING CLIP IS ALWAYS DISCONNECTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4OSU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R