BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAC 5000

    MDR report key: 710261 · Received March 2, 2006

    Report

    Report Number
    710261
    Event Type
    Other
    Date Received
    March 2, 2006
    Date of Event
    March 1, 2006
    Report Date
    March 2, 2006
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    DPS
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CAME TO OUTPATIENT DEPARTMENT FOR AN EKG PRIOR TO STARTING SOME NEW MEDICATIONS. WHILE 12- LEAD BEING RUN, MACHINE NOTED ACUTE MYOCARDIAL INFARCTION. PT WAS ASYMPTOMATIC. STAFF TRIED TO TROUBLESHOOT MACHINE: READJUSTED LEADS, CHECKED ALLIGATOR CLIPS, RE-RAN AND HAD OTHER STAFF COME TO CHECK. PT TAKEN TO ED WHERE ASSESSED AND ANOTHER EKG DONE. NO MYOCARDIAL INFARCTION. PT DISCHARGED TO HOME. NO HARM.BIOMED CALLED AND CHECKED THE EKG MACHINE. RAN SEVERAL TESTS AT 30BPM, 60BPM & 120BPM. NO PROBLEMS FOUND ON READINGS. STAFF CHANGED 4 LEAD CONNECTOR CLIPS. UNABLE TO DUPLICATE FINDINGS IN ANY OF THE TESTS RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAC 5000 ELECTROCARDIOGRAM DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MAC-5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR