BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL ELECTRIC MEDICAL SYSTEMS

    MDR report key: 417501 · Received September 17, 2002

    Report

    Report Number
    MW1026215
    Event Type
    Malfunction
    Date Received
    September 17, 2002
    Date of Event
    September 5, 2002
    Report Date
    September 17, 2002
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT MONITOR BEGAN RECYCLING ITSELF WHILE IN USE. MONITOR WAS BEING USED TO MONITOR ECG, SPO2 AND NIBP ON A PT. MONITOR WAS BRAND NEW AND HAD ONLY BEEN IN USE FOR ONE DAY. BECAUSE PT REQUIRED CONSTANT MONITORING THIS PROBLEM WAS A REAL HAZARD TO THE HEALTH OF THE PT. MONITOR WAS SWAPPED OUT WITH A KNOWN GOOD UNIT AND PROBLEM REPORTED TO OEM. SAME PROBLEM OCCURRED ON LOANER UNIT SUPPLIED BY OEM. TWO BRAND NEW MONITORS, TWO VERY SERIOUS PROBLEMS, POSSIBLE TREND?

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/27/02: THIS IS IN RESPONSE TO LETTER OF OCTOBER 31, 2002, WHICH MFR RECEIVED NOVEMBER 18, 2002, IN REGARD TO MW1026215. THE REPORT HAD BEEN FILED BY UF IN REFERENCE TO A DASH MONITOR MANUFACTURED BY GE MEDICAL SYSTEMS INFO TECHNOLOGIES. MFR HAS NO MDR REPORTS, NOR ANY COMPLAINTS ON FILE FROM THIS RPTR ON THIS PRODUCT. AS SUCH, MFR HAS NO RECORD OF RECEIVING THE DEVICE BACK FOR INVESTIGATION, AND THEREFORE CANNOT PROVIDE DETAILS, AS REQUESTED IN LETTER. MFR CALLED THE RPTR ON NOVEMBER 18, INQUIRING ABOUT THE MEDWATCH REPORT. CLINICAL ENGINEERING RETURNED CALL ON NOVEMBER 19, AND STATED THAT RPTR WAS NO LONGER EMPLOYED AT USER FACILITY AND THAT THEY HAD NO KNOWLEDGE OF ANY ISSUE WITH THE DASH MONITORS AT THAT HOSPITAL. MFR SENT CLINICAL ENGINEERING A COPY OF THE MEDWATCH REPORT AND ASKED THEM TO INVESTIGATE ON THEIR END, SO THAT MFR COULD RESPOND TO LETTER. ON NOVEMBER 25, THEY SENT A STATEMENT, INDICATING THAT DESPITE INVESTIGATION AND DISCUSSION WITH OTHER PARTIES AT THE HOSPITAL, THEY WERE NOT ABLE TO CONFIRM ANY DETAILS ABOUT THE REPORT, AND IS UNAWARE OF ANY DEVICE ISSUES WITH THE DASH MONITORS AT FACILITY. AS OF 11-25-02 NO PROBLEMS HAVE BEEN FOUND WITH THIS PIECE OF EQUIPMENT SINCE 9/17/02. UF HAS INSPECTED THIS UNIT AND OTHERS LIKE IT AND HAVE FOUND NO PROBLEMS CONCERNING THE FUNCTIONS OF THIS MACHINE FOR EXAMPLE THE PROBLEMS REPORTED. THEY ATTRIBUTE THE PROBLEM, AFOREMENTIONED, TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC MEDICAL SYSTEMS PATIENT MONITOR DRT GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DASH 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other