BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND-GE 400

    MDR report key: 232494 · Received July 19, 1999

    Report

    Report Number
    MW1016765
    Event Type
    Malfunction
    Date Received
    July 19, 1999
    Report Date
    July 19, 1999
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    LXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE RPTR RECENTLY BECAME AWARE OF A SOFTWARE ERROR WHILE UTILIZING THE DEVICE. THE RPTR STATES THAT THE DEVICE ANALYZES (VIA ULTRASOUND) VARIOUS "SIZES" OF A FETUS, AND CREATES RATIOS BASED ON THIS DATA. THE RPTR STATES THAT CERTAIN RATIOS ARE ONLY OF VALUE DURING CERTAIN STATES OF THE GESTATIONAL PERIOD. HE STATES THAT EVEN THOUGH A RATIO MAY NOT BE APPLICABLE DURING A CERTAIN GESTATIONAL PERIOD, THE DEVICE WILL GENERATE A RATIO, AND DISPLAY THIS VALUE AS "ABNORMAL". THE RPTR FEELS THAT THIS IS PROBLEMATIC FOR TWO REASONS: IF AN MD IS NOT THOROUGHLY READING THE RESULTS, THEY MAY INCORRECTLY INFORM A PT THAT SHE HAS AN "ABNORMAL" PREGNANCY; AND IF A DR IS USED TO IGNORING THE "ABNORMAL" READINGS, THEY MAY, IN FACT, OVERLOOK A TRUE ABNORMAL RESULT. THE RPTR STATES THAT A COMPETITOR'S SOFTWARE GENERATES "NA" FOR VALUES THAT WOULD BE INCORRECTLY REPRESENTED BY THE RATIO. HE FEELS THAT THIS SOFTWARE SHOULD BE DESIGNED IN THE SAME MANNER. THE RPTR CONTACTED THE MFR REGARDING THIS EVENT, AND HE WAS TOLD THAT 50 MD'S WERE ASKED IF THIS WOULD BE A PROBLEM, AND THEY STATED THAT "IT WAS OK". THE RPTR DOES NOT BELIEVE THAT THIS INFO IS CORRECT/ADEQUATE. TO THE RPTR'S KNOWLEDGE, NO PT INJURY HAS BEEN SUSTAINED AS A RESULT OF THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND-GE 400 ULTRASOUND LXE GENERAL ELECTRIC MEDICAL SYSTEMS GE 400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other