BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYPCMA+1

    MDR report key: 1180228 · Received September 29, 2008

    Report

    Report Number
    1045510-2008-00014
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    September 7, 2004
    Report Date
    September 26, 2008
    Manufacturer
    HILL-ROM CHARLESTON
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN A HILL-ROM TECHNICIAN RESPONDED TO THE ACCOUNT'S ALLEGATION, HE REMOVED THE CONTROL UNIT FROM THE FOOTBOARD OF THE BED. THERE WAS NO INDICATION OF HOW THE UNIT WAS PERFORMING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO HILL-ROM THAT THE PATIENT'S LEFT FOOT WAS RESTING AGAINST THE CONTROL UNIT. THE CUSTOMER ALLEGED THAT THE PATIENT SUSTAINED THREE 2ND DEGREE BURN AREAS ON THE LEFT FOOT. A HILL-ROM TECHNICIAN REMOVED THE UNIT FROM THE FOOTBOARD. DUE TO THE AGE OF THE COMPLAINT, NO FURTHER INFO COULD BE OBTAINED REGARDING THE ALLEGED INJURY. 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 SYPCMA+1 SYNERGY PULSE IKY HILL-ROM CHARLESTON 5609

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR