BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGO M2

    MDR report key: 21918781 · Received April 28, 2025

    Report

    Report Number
    MW5169552
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SUNTECH MEDICAL, INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS SCHEDULED FOR A PROCEDURE WHERE THE BLOOD PRESSURE IS TAKEN EVERY MINUTE FOR THE FIVE-MINUTE TEST. THE BASELINE BLOOD PRESSURE DID NOT CAUSE HER ANY DISCOMFORT. DURING THE SECOND BLOOD PRESSURE SHE COMPLAINED THAT THE CUFF WAS TIGHT. DURING THE THIRD BLOOD PRESSURE SHE VERY LOUDLY EXPRESSED THAT SHE WAS IN PAIN. THE RN REMOVED THE CUFF FROM HER UPPER ARM AND APPLIED A DIFFERENT CUFF TO HER WRIST. THE AUTOMATED CUFF WAS FUNCTIONING PROPERLY. THE CUFF HAS A MICROPHONE THAT DETECTS THE KOROTKOFF SOUNDS. THE MACHINE HAS A MAXIMUM INFLATION OF 280 MMHG (5.4 PSI). IT DID NOT INFLATE HIGHER THAN THIS. THE BP UNIT HAS BEEN REMOVED FROM SERVICE AND WILL BE SENT TO THE VENDOR FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480871 TANGO M2 SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN SUNTECH MEDICAL, INC. 2130

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention