BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXISKY 600

    MDR report key: 2861822 · Received November 29, 2012

    Report

    Report Number
    9681684-2012-00096
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG IINC.
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE STAFF MEMBER HAD COMPLETED THE TRANSFER OF THE RESIDENT BACK TO HER BED AND WAS POSITIONING THE MOTOR BACK TO THE CHARGING STATION. SHE WAS HOLDING THE HANGER BAR CLOSE TO THE STRAP, TO MANEUVER THE LIFT TO ITS CHARGING STATION. WHEN THE DEVICE CONNECTED TO THE CHARGING STATION, IT STARTED TO RAISE UP AND WENT PAST THE UPPER LIMIT SWITCH, AND BECAUSE THE HANGER BAR WAS ONLY INCHES FROM THE MOTOR, AND IT HAPPENED SO FAST THE STAFF MEMBER'S FINGERS WERE CAUGHT BETWEEN THE CEILING LIFT AND THE SPREADER BAR. SHE WAS ABLE TO PULL THE EMERGENCY CORD AND GET HER FINGERS OUT. SHE HAD A FRACTURE TO THE 3RD FINGER, AND A POSSIBLE FRACTURE TO THE 2ND FINGER, WITH SPLINT APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FNG ARJOHUNTLEIGH MAGOG IINC. LD10211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other