BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARD SYNERGY PLUS/PULSE

    MDR report key: 1180229 · Received September 29, 2008

    Report

    Report Number
    1045510-2008-00016
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    May 29, 2007
    Report Date
    September 26, 2008
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE CONTROL UNIT WAS GETTING REALLY HOT AND PUT A BLISTER ON THE PATIENT'S FOOT. A HILL-ROM TECHNICIAN REMOVED THE PRODUCT FROM THE ACCOUNT. AN INVESTIGATION COULD NOT REPRODUCE THE FAILURE. DURING AN INVESTIGATION OF THIS PRODUCT LINE IT WAS FOUND THAT IT IS 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