BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANS-1

    MDR report key: 9123949 · Received September 25, 2019

    Report

    Report Number
    MW5090042
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 23, 2019
    Manufacturer
    LD TECHNOLOGY LLC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    TM-FLOW REPORT (HTTPS://WWW.LDTECK.COM/ANS-1) INDICATED POOR CARDIAC OUTPUT AND ANS DYSFUNCTION WHICH THE PT DIDN'T HAVE. THE EQUIPMENT CONSTANTLY MALFUNCTIONS EACH TIME IT IS TURNED ON. EITHER THE PULSE OX OR ONE OR SEVERAL OF THE BLOOD PRESSURE CUFFS DOES NOT WORK. THEY HAVE BEEN RESET MANY TIMES BY IT AND MALFUNCTION AGAIN ONCE THE SYSTEM IS BOOTED UP THE NEXT TIME. LD TECH IS PUSHING DEVICE THAT DOESN'T SEEM TO PRODUCE RELIABLE TEST RESULTS FOR USE IN DIAGNOSIS OF CARDIAC AND NEUROPATHY DYSFUNCTIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909494 ANS-1 OXIMETER DQA LD TECHNOLOGY LLC A1VSV133

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R