BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLTER MONITOR

    MDR report key: 17536416 · Received August 12, 2023

    Report

    Report Number
    MW5143304
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    January 5, 2022
    Manufacturer
    UNKNOWN
    Product Code
    MWJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE SUBJECT MENTIONED THAT HE HAD DIFFICULTIES KEEPING THE HALTER LEADS ON DURING MONITORING. (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
    1355681 HOLTER MONITOR ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ UNKNOWN UNKNOWN - HOLTER MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown