BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON XP

    MDR report key: 221608 · Received April 30, 1999

    Report

    Report Number
    2936884-1999-00002
    Event Type
    Malfunction
    Date Received
    April 30, 1999
    Date of Event
    April 1, 1999
    Report Date
    April 30, 1999
    Manufacturer
    ACUSON CORP.
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE ACUSON XP REVISION 27 OUTPUTS 4-DIGIT YRS IN THE "OB" REPORT, IN COMPLIANCE WITH THE NEED TO SUPPORT THE YEAR 2000 REQUIREMENT. WHILE THE XP REVISION 27 SHOWS 4-DIG YRS ON THE XP SYSTEM MONITOR, USING REVISION 27.125 THE LAST DIGIT OF THE CURRENT EXAM DATE (CED) IS TRUNCATED IN THE REPORT OUTPUT FROM THE XP PARALLEL PORT, SO THAT THE YEAR 1999 IS OUTPUT AS "199." THE DIGISONICS SOFTWARE PRIOR TO REVISION 9.0, WHICH HAS NOT BEEN MODIFIED TO ACCOUNT FOR THE ABOVE ERROR IN DATA TRANSMISSION FROM THE XP, INTERPRETS THE "199" AND SHOWS THE CURRENT EXAM YEAR OF "9." AS A RESULT, THE CED AS SHOWN ON THE DIGISONICS OB REPORT IS INCORRECTLY SHOWN. ON 2/22/99 THE DIGISONICS OB-500 SYSTEM CALCULATED AN INCORRECT FETAL DUE DATE (EDD) BECAUSE OF AN INCORRECT STUDY DATE TRANSMITTED FROM THE ACUSON SYSTEM VIA THE DIGISONICS SOFTWARE OBLINK. AS A RESULT A PHYSICIAN DELIVERED A BABY BY C-SECTION APPROX 3 WEEKS PREMATURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSON XP ULTRASOUND IMAGING DEVICE IYO ACUSON CORP. 128XP REV. 27.125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| L| R