BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

    MDR report key: 11071827 · Received December 24, 2020

    Report

    Report Number
    11071827
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 22, 2020
    Manufacturer
    THE SCOTTCARE CORPORATION
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TELEMETRY SYSTEM IN CARDIAC REHAB WAS MALFUNCTIONING. SOME (NOT ALL) CARDIAC MONITORS LOST SIGNAL, AND WERE NOT ABLE TO PROVIDE ELECTROCARDIOGRAM TRACINGS. THIS PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537730 ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ THE SCOTTCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1