BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALYPSO

    MDR report key: 760931 · Received September 13, 2006

    Report

    Report Number
    9611530-2006-00033
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    April 28, 2006
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR HAS EXAMINED THE DEVICE AND FOUND THE OVER-ALL CONDITION OF THE LIFT APPEARS BETTER THAN AVERAGE. THERE ARE NO TEARS, DENTS, OR PEELING PAINT. IT WAS POSSIBLE TO MAKE LIFT RUN IN THE DOWN MODE. WITHOUT TOUCHING THE HAND CONTROL. ON APPROXIMATELY OCTOBER 21, 2005, THE PILLAR COVER, CABLE MICROSWITCH COMPLETE, REMOTE HAND CONTROL, AND PRINTED CIRCUIT BOARD WERE ORDERED AND INSTALLED ON THE UNITY BY THE FACILITY MAINTENANCE. REPORTS FROM THE SITE INDICATE THE HANDSET/CONNECTOR HAD BEEN EXPOSED TO WATER, MAKING A SHORT CIRCUIT, WHICH CAUSED THE UNWANTED MOVEMENT. THE PARTS IN QUESTION WERE NOT MADE AVAILABLE FOR INVESTIGATION. THE MANUFACTURER RECOMMENDS THE HAND CONTROL AND POSSIBLY CONNECTOR BE REPLACED TO PREVENT A RECURRENCE OF THE EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT WAS ON THE LIFT, READY TO BATH. AT THIS POINT, THE LIFT BEGAN LOWERING ON ITS OWN, CAUSING INJURY TO THE LEFT ANKLE AND LOWER CALF AREA OF THE RESIDENT. MAINTENANCE WAS CALLED TO AID IN THE REMOVAL OF THE RESIDENT FROM THE LIFT TO CHECK THE LIFT MALFUNCTION. RESIDENT SUSTAINED A LACERATION AND FRACTURE TO THE LEFT ANKLE AREA. SUTURES WERE APPLIED TO THE LEFT ANKLE AREA AND BELOW THE LEFT KNEE IN THE SOFT CALF AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALYPSO LIFT HYGIENE CHAIR FSA ARJO HOSPITAL EQUIPMENT AB CDBXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Required Intervention