BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TZ MEDICAL INC. CLARUS 40M

    MDR report key: 7846416 · Received September 4, 2018

    Report

    Report Number
    MW5079561
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 16, 2018
    Report Date
    August 20, 2018
    Manufacturer
    TZ MEDICAL
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TELEMETRY MONITOR NEEDED RECHARGE MORE OFTEN THAN 24 HOURS OFF MONITOR FOR CHARGING 3 TO 4 HOURS. SOMETIMES CHARGING GUIDE NOT WORKING. NEED TO BE AT AN ELECTRICAL OUTLET TO CHARGE RESTRICTING TIME AVAILABLE TO CHARGE UNIT. KEPT GETTING ERROR MESSAGES, HAD TO POWER OFF AND RESTART TO CLEAR MESSAGE. AT ONE POINT THESE MESSAGES WERE HAPPENING AT LEAST CALLED MOBILE CARDIAC MONITORING REGARDING MALFUNCTION. THEY WERE UNABLE TO PROVIDE ANY ADVICE ON FIXING PROBLEM. TODAY THEY ARE GOING TO DELIVER A NEW DEVICE, 5 DAYS LATER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685656 TZ MEDICAL INC. CLARUS 40M DETECTOR AND ALARM ARRHYTHMIA DSI TZ MEDICAL 01 0 0811331 01153 1 21 H3R3300989

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention