BEUDAMED
    FDA Adverse Event Other Summary report: N

    AI5200A DIAGNOSTIC ULTRASOUND IMAG. & TRANSDUCER

    MDR report key: 116116 · Received August 22, 1997

    Report

    Report Number
    116116
    Event Type
    Other
    Date Received
    August 22, 1997
    Date of Event
    August 6, 1997
    Report Date
    August 6, 1997
    Manufacturer
    DORNIER SURGICAL PRODUCTS, INC.
    Product Code
    ITX
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    8/6/97...EXAM TECHNICIAN REPORTED THAT 2 PATIENTS RECEIVING ABDOMINAL SCANS SAID THAT THEY FELT A TINGLE FROM THE 3.5/20 CLA TRANSDUCER. THE TECH FELT IT ALSO. 8/6/97...DMSI SERVICE ENGINEER PERFORMED A LEAKAGE TEST ON THE A15200A SYSTEM USING A SIMPSON 229-2 LEAKAGE TESTER, CAL DATE: 9/97. LEAKAGE CURRENT READING WERE 0.0MA ON 0.01MA SCALE WHICH IS ACCEPTABLE. NO PROBLEM FOUND. 8/11/97...TRANSDUCER RETURNED TO DSPI. 8/11/97....DSPI SENT TRANSDUCER TO AI FOR FURTHER EVALUATION. 8/11/97...AI PERFORMED STANDARD IMAGING AND HIGH VOLTAGE SAFETY TESTING. HIGH POT TESTING AT 3000VAC INDICATED LESS THAN 0.5 MA OF CURRENT AND PT LEAKAGE VALUES NOMINAL. NO PROBLEM FOUND WITH TRANSDUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AI5200A DIAGNOSTIC ULTRASOUND IMAG. & TRANSDUCER ULTRASOUND SYSTEM AND TRANSDUCER ITX DORNIER SURGICAL PRODUCTS, INC. 5200-0001-1A/2101-0018-1B *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other