BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G.E. MEDICAL

    MDR report key: 313956 · Received January 26, 2001

    Report

    Report Number
    MW1020928
    Event Type
    Malfunction
    Date Received
    January 26, 2001
    Date of Event
    January 12, 2001
    Report Date
    January 22, 2001
    Manufacturer
    G.E. MEDICAL
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED FROM SURGERY AND PLACED ON BEDSIDE MONITOR WITH NORMAL SINUS RHYTHM. PT WAS THEN PLACED ON AN ULTRA FILTRATION DEVICE (CVVHD). AFTER PT WAS STARTED ON TREATMENT A CHANGE IN RHYTHM WAS NOTED. PT APPEARED TO BE IN ATRIAL FLUTTER AND WAS CARDIOVERTED AND TREATED WITH MEDICATION. A 12 LEAD WAS THEN DONE ON THE PT. THE 12 LEAD INDICATED NSR. THE CVVHD WAS THEN TURNED OFF AND THE RHYTHM WENT INTO NSR ON THE MONITOR. CHANGED CABLING AND MONITOR MODULE. NO CHANGE IN RHYTHM. CVVHD WAS CHANGED OUT WITH NO POSITIVE RESULTS, STILL ATRIAL FLUTTER. BIO-ENGINEERING CHECKED ALL EQUIPMENT GROUNDS AND FOUND NO FAULT. BIO-ENGINEERING THEN CHANGED THE EKG PATCHES. REPOSITIONING AND CHANGING THE PATCHES DID IMPROVE THE DISPLAYED ECG WAVEFORM. SLIGHT ARTIFACT WAS STILL NOTED ON THE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3234 G.E. MEDICAL PATIENT MONITOR DRT G.E. MEDICAL SOLAR 8000 450SL *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other