BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORTARA ELECTROCARDIOGRAPH

    MDR report key: 12835547 · Received November 17, 2021

    Report

    Report Number
    MW5105423
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    November 12, 2021
    Report Date
    November 15, 2021
    Manufacturer
    MORTARA / WELCH ALLYN, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FLASH OF LIGHT AND SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724537 MORTARA ELECTROCARDIOGRAPH ELECTROCARDIOGRAPH DPS MORTARA / WELCH ALLYN, INC. ELI380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown