BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO M2

    MDR report key: 13009674 · Received December 15, 2021

    Report

    Report Number
    13009674
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    October 19, 2021
    Report Date
    December 1, 2021
    Manufacturer
    SUNTECH MEDICAL, INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TANGO M2 STRESS TEST MONITOR FAILING TO PROVIDE PROPER BLOOD PRESSURE READING. "EXCESSIVE ARM MOVEMENT OR MICROPHONE NOISE." IS AN ERROR MESSAGE RECEIVED AFTER MULTIPLE TRIES, USING MULTIPLE CUFFS. THIS DEVICE (AUTOMATIC-INFLATION ELECTRONIC SPHYGMOMANOMETER) HAS FAILED IN THE PAST WITH THE SAME PROBLEM. VENDOR CHECKED IT AND REPORTED NO ISSUE FOUND. THE DEVICE WAS SENT AGAIN FOR THE SAME PROBLEM, AND THE UNIT WAS JUST RECEIVED AND STILL SHOWING THE SAME PROBLEM, EVEN THOUGH THE VENDOR SAYING NO PROBLEM WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906791 TANGO M2 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN SUNTECH MEDICAL, INC. 99-0088-51

    Patients

    Seq Age Sex Outcome Treatment
    1 36135 DA Unknown