BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYPCMA+1

    MDR report key: 1180226 · Received September 29, 2008

    Report

    Report Number
    1045510-2008-00010
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    December 16, 2004
    Report Date
    September 24, 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 THERE WAS A BLOWER MALFUNCTION. CUSTOMER ALLEGED THAT THE UNIT BURNED THE PATIENT'S FOOT. A HILL-ROM TECHNICIAN REMOVED THE PRODUCT FROM THE ACCOUNT. AN INVESTIGATION COULD NOT REPRODUCE THE MALFUNCTION. THE PATIENT SUSTAINED A 2ND DEGREE BURN ON HIS FOOT JUST UNDER THE BIG TOE. 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 SYPCMA+1 SYNERGY PULSE IKY HILL-ROM CHARLESTON 5609

    Patients

    Seq Age Sex Outcome Treatment
    1