BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

    MDR report key: 17523585 · Received August 12, 2023

    Report

    Report Number
    MW5130533
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    July 1, 2021
    Manufacturer
    UNKNOWN
    Product Code
    MWJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MONITOR REPORTEDLY NOT READING TELEMETRY (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565130 ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ UNKNOWN DR220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown