BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE TYPE 8558 ULTRASOUND SYSTEM

    MDR report key: 25173 · Received August 1, 1995

    Report

    Report Number
    25173
    Event Type
    Malfunction
    Date Received
    August 1, 1995
    Date of Event
    June 26, 1995
    Report Date
    July 6, 1995
    Manufacturer
    U.S. MEDICAL CORP.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CO ULTRASOUND MACHINE WAS NON-FUNCTIONAL MANY TIMES DURING A POSSIBLE CRYO-ABLATION PROCEDURE WHILE PT WAS ANESTHETIZED. PROBE INVOLVED WAS ANOTHER DEVICE. PT WAS UNDER ANESTHESIA MUCH LONGER THAN NECESSARY. ALSO NEEDLE PLACEMENT FOR I 125 SEEDING WAS IMPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROBE TYPE 8558 ULTRASOUND SYSTEM ULTRASOUND SYSTEM IYN U.S. MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR