BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORTARA SOFTWARE

    MDR report key: 7889188 · Received September 18, 2018

    Report

    Report Number
    MW5079875
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    June 21, 2018
    Report Date
    September 17, 2018
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ECG READING INDICATING ATRIAL FLUTTER WAS NOT CORRECT. METOPROLOL WAS ADMINISTERED AND THE PT WENT INTO PEA ARREST BUT RECOVERED, BY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728514 MORTARA SOFTWARE ELECTROCARDIOGRAPH DRX MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening