BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 380

    MDR report key: 17780301 · Received September 20, 2023

    Report

    Report Number
    17780301
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 7, 2023
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IN FOR CHEST PAIN TO ED, ATTEMPTED EKG BUT EKG MACHINE MALFUNCTIONED. DELAY IN OBTAINING EKG ON THIS PATIENT FOR 30 MIN D/T EQUIPMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059368 ELI 380 ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC. ELI 380

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA Unknown