BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOUND PROBE

    MDR report key: 247537 · Received October 27, 1999

    Report

    Report Number
    2916737-1999-00001
    Event Type
    Injury
    Date Received
    October 27, 1999
    Date of Event
    October 6, 1999
    Report Date
    October 27, 1999
    Manufacturer
    DIASONICS ULTRASOUND INC.
    Product Code
    IYO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT AN ANESTHETIZED PT REC'D A THIRD DEGREE BURN TO THE ABDOMEN DURING A DIAGNOSTIC ULTRASOUND EXAMINATION. THE ELEVATED TEMPERATURE RESULTED FROM AN APPARENT MALFUNCTION OF THE MECHANICAL DRIVE SYSTEM RATHER THAN FROM EXCESSIVE ULTRASOUND RADIATION. THIS APPEARS TO BE AN ISOLATED OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND PROBE DIAG. ULTRASOUND IYO DIASONICS ULTRASOUND INC. DRF 400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention