BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATL

    MDR report key: 545126 · Received July 15, 2004

    Report

    Report Number
    MW1032742
    Event Type
    Other
    Date Received
    July 15, 2004
    Date of Event
    January 1, 2004
    Report Date
    July 15, 2004
    Manufacturer
    PHILLIPS
    Product Code
    ITX
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTS MACHINE SHUTTING DOWN DURING USE ON NUMEROUS PTS. THIS UNPREDICTABLE MALFUNCTION JEOPARDIZES PT CARE AND PT HEALTH. THERE HAS BEEN SIGNIFICANT TRAUMA AND INCONVENIENCE TO PTS. MACHINE HAS BEEN REPAIRED SEVERAL TIMES BUT IS STILL SHUTTING DOWN DURING ASPIRATION AND BIOPSIES. DEVICE IS DEFECTIVE, UNRELIABLE AND UNSAFE TO THE RPTR'S PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATL ULTRASOUND MACHINE ITX PHILLIPS HDI 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other