BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDILYNX POCKET ECG 4 CARDIAC EVENT MONITOR

    MDR report key: 17201417 · Received June 23, 2023

    Report

    Report Number
    MW5118806
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 20, 2023
    Manufacturer
    REACT DX/MEDILYNX/MEDICALGORITHMICS S.A.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 30-DAY CARDIAC EVENT MONITOR QUIT WORKING AFTER 15 DAYS. PATIENT CALLED HELP LINE NUMBER PROVIDED IN THE PATIENT PRODUCT PAMPHLET AND HIS CALL WAS NOT RETURNED NOR ANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265165 MEDILYNX POCKET ECG 4 CARDIAC EVENT MONITOR DETECTOR AND ALARM, ARRHYTHMIA DSI REACT DX/MEDILYNX/MEDICALGORITHMICS S.A. POCKET ECG4

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male