BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5078904

    MDR report key: 7757418 · Received August 6, 2018

    Report

    Report Number
    MW5078904
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    January 1, 2016
    Report Date
    August 2, 2018
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBJECT-REGARDING ULTRASOUND MACHINE WHICH HAS DEFECT IN RUNNING APPLICATION SINCE INSTALLATION; RESPECTED SIR/MADAM, MYSELF FROM (B)(6) CLINIC PURCHASED ULTRASOUND MACHINE 2 YEARS BACK (ECUBE 7) WHICH COMPANY SAY THAT IT'S FDA APPROVED, I WOULD LIKE TO PAY YOUR ATTENTION THAT 1 APPLICATION IS NOT WORKING IN THIS MODEL. THERE IS NO SATISFACTORY ANSWER AS WELL AS SOLUTION FOR THE ALPINION COMPANY SINCE MORE THAN 2 YEAR. PROBLEM IS WITH ECHOCARDIOGRAPHY - TDI (TISSUE DOPPLER IMAGING) WHICH HAS 2 PARTS. (1) PW-TDI, (2) COLOR-TDI. BOTH HELPS IN DIAGNOSIS. SECOND PART WHICH IS COLOR TDI IS NOT WORKING IN ABOVE SAID MODEL. WHEN ASKED ABOUT THIS PROBLEM TO THE CONCERNED COMPANY PEOPLE THEY DID NOT GIVE ANY SOLUTION OR SATISFACTORY ANSWER FOR THIS PROBLEM. IT'S ALMOST BEEN 2 YEAR BUT NO SOLUTION TILL NOW. ONCE IF IT'S APPROVED BY FDA THEN COMPANY SHOULD PROVIDE APPLICATION WHICH SHOULD BE WORKING. HOPE YOU WILL LOOK INTO THE MATTER AND SOLVE IT SOON. DETAIL OF COMPANY BELOW COMPANY NAME - (B)(6).

    Patients

    Seq Age Sex Outcome Treatment
    1 Other