BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P600 PORTABLE CEILING LIFT

    MDR report key: 4084727 · Received August 29, 2014

    Report

    Report Number
    3007802293-2014-00023
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 29, 2014
    Manufacturer
    PRISM MEDICAL
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIPT OF THE COMPLAINT, PRISM MEDICAL QUALITY, ENGINEERING, AND PROJECT MANAGEMENT STAFF LOOKED AT AN IN-STOCK P440. IT WAS FOUND THAT IF THE HAND CONTROL CORD WAS KINKED EITHER IN THE HOOKS OF THE LIFT OR BY HAND, THE UNIT COULD CONTINUE UP TO THE UPPER LIMIT SWITCH. IT WAS ALSO NOTED THAT THE E-DOWN WAS ABLE TO LOWER EVEN IF THE LIFT WAS CONTINUING UPWARDS. IN ADDITION, THE POWER CUT-OFF FUNCTIONED BY CUTTING OFF POWER TO THE LIFT. THE DOWN BUTTON ON THE LIFT STOPPED THE UPWARD MOTION AS WELL. A PRISM PROJECT MANAGER VISITED THE CUSTOMER ON (B)(6) TO GATHER MORE DETAILS AND TO FURTHER VERIFY THE COMPLAINT. HE REPEATED A SIMILAR EXPERIMENT WITH THE CUSTOMER'S P600, TESTING TO ENSURE THE E-DOWN, POWER OFF, AND DOWN BUTTON STOPPED UPWARD MOTION OF THE LIFT WHEN THE HAND CONTROL CORD WAS KINKED. AS THE HAND CONTROL OPERATES USING PNEUMATICS, WHEN THE CORD IS KINKED PRESSURE REMAINS IN THE LINE AND THE BUTTON WILL STAY DEPRESSED. IT IS IMPORTANT THAT CARE IS TAKEN WHEN LIFTING ANY PATIENT. WE ARE DESIGNING A NEW GENERATION OF PORTABLE LIFT TO BE RELEASED IN 2015 WHICH FEATURES A DIGITAL HAND CONTROL. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A P600 WAS BEING USED TO REPOSITION A PATIENT USING A DISPOSABLE REPOSITIONING SLING. ONLY ONE SIDE OF THE SLING WAS CONNECTED TO THE LIFT AS THE INTENT OF THE TRANSFER WAS TO ROLL THE PATIENT ONTO HIS SIDE. THE HAND CONTROL CORD WAS WRAPPED AROUND THE CARRY BAR ON THE LIFT AND THE SLING WAS PLACED ON TOP OF THE HAND CONTROL CORD. ONCE THE UP BUTTON WAS ENGAGED, THE WEIGHT OF THE PATIENT CRIMPED THE HAND CONTROL CORD CAUSING THE LIFT TO CONTINUE RAISING AFTER THE BUTTON HAD BEEN RELEASED. THE MOTOR CONTINUED UP UNTIL THE UPPER LIMIT WAS ENGAGED. THE PATIENT WAS ROLLED ONTO HIS STOMACH ON THE BED. THE PATIENT HAD BROKEN RIBS PRIOR TO THE EVENT AND WAS ON A VENTILATOR. THE INCIDENT CAUSED PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527534 P600 PORTABLE CEILING LIFT P600 FSA PRISM MEDICAL 303090

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR