BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARD SYNERGY PLUS/PULSE

    MDR report key: 1180224 · Received September 29, 2008

    Report

    Report Number
    1045510-2008-00017
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    November 15, 2007
    Report Date
    September 26, 2008
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF THE HILL-ROM ENGINEERING INVESTIGATION ARE AS FOLLOWS: OUTPUT OF AIR REACHED 146.8 DEGREES FAHRENHEIT AFTER 1.5 HOURS OF OPERATION. THE AIR MANIFOLD WAS TAPED IN PLACE, THE PLATE TO CONTROL THE BLOWER MOTOR COOLING AIR WAS NOT SECURE AND THE HEATED AIR OFF OF THE MOTOR WAS DISCHARGED WITHIN THE BLOWER COMPARTMENT AND BEING PULLED INTO THE INTAKE OF THE BLOWER, THE O RINGS OF THE MANIFOLD PLUG WERE COMPRESSED AND TOOK A SET, THIS ALLOWED THE PLUG NOT TO BE SECURE AND TIGHT WHICH ALLOWS HEATED AIR TO RECIRCULATE IN THE BLOWER COMPARTMENT, FITTINGS AND TUBING ON THE MANIFOLD WERE NOT SECURE AND TIGHT WHICH LEAKED AIR, A HOSE FITTING WAS DEFORMED DUE TO HEAT WHICH ALLOWED IT TO LEAK AIR. ALL OF THESE CONDITIONS COULD HAVE CONTRIBUTED TO THE EXTERNAL AIR OUTPUT REACHING A TEMPERATURE OF 146.9 DEGREES FAHRENHEIT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE MATTRESS WAS BURNING THE PATIENT'S FOOT. A HILL-ROM TECHNICIAN FOUND THAT THE UNIT WAS WORKING WITHIN SPECIFICATION. A FURTHER INVESTIGATION OF THE UNIT FOUND THAT THE OUTPUT OF THE AIR REACHED 146.8 DEGREES FAHRENHEIT AFTER 1.5 HOURS OF OPERATION. DURING AN INVESTIGATION OF THIS PRODUCT LINE IT WAS FOUND THAT IS IT POSSIBLE FOR AN EXTERNAL COMPONENT ON THE PRODUCT TO REACH A TEMPERATURE ABOVE THAT WHICH IS ALLOWABLE FOR BRIEF PATIENT CONTACT. ALL ALLEGATIONS OF INJURY (REGARDLESS OF SEVERITY) DUE TO THIS FAILURE MODE ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARD SYNERGY PLUS/PULSE SYNERGY PULSE IKY HILL-ROM CHARLESTON 5609

    Patients

    Seq Age Sex Outcome Treatment
    1