BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSON CYPRESS ULTRASOUND SYSTEM

    MDR report key: 395762 · Received May 14, 2002

    Report

    Report Number
    MW1025101
    Event Type
    Injury
    Date Received
    May 14, 2002
    Date of Event
    November 1, 2001
    Report Date
    May 14, 2002
    Manufacturer
    ACUSON CORPORATION, NOW OWNED BY SIEMENS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH THE ACUSON CYPRESS ECHOCARDIOGRAM EQUIPMENT NOW OWNED BY SIEMENS CORP. CARDIOLOGY OFFICE ACQUIRED ONE OF THE NEW CYPRESS SYSTEMS IN OCT 2000. THE CYPRESS SYSTEM, ORIGINALLY MANUFACTURED BY ECTON, WAS SOLD TO ACUSON. ACUSON WAS SUBSEQUENTLY ACQUIRED BY SIEMENS. IN NOV 2001, THE ACUSON CO SENT SOFTWARE UPDATES FOR THE CYPRESS MACHINE. REPORTER UPDATED AS INSTRUCTED WITHOUT DIFFICULTY. AFTER THE UPGRADE, THEY BEGAN TO NOTICE DEGRADATION IN THE IMAGING QUALITY. THE PROBLEM WAS NOT FULLY REALIZED UNTIL THEY HAD THE OPPORTUNITY TO EXAMINE THE SAME PTS REPEATEDLY AND NOTICED A SIGNIFICANT DEGREE OF IMAGE DEGRADATION. FOR EXAMPLE, BEFORE THE UPGRADE, THE SEVERITY OF A VALVULAR REGURGITATION WAS "MODERATE". AFTER THE UPGRADE, THE TEST ON THE SAME PT FOUND THE SEVERITY OF REGURGITATION TO BE "MILD". THIS SECOND TEST WOULD LEAD REPORTER TO BELIEVE, AND TREAT THE PT AS IF THE PT WAS IN BETTER HEALTH THAN THEY REALLY WERE. AFTER THEY REALIZED THE PROBLEM, REPORTER CONTACTED SIEMENS ON APRIL 2002. DURING THIS INITIAL CONTACT, SIEMENS TOLD REPORTER THAT THEY UPGRADED THE SOFTWARE TO WORK WITH AN "IN-HOUSE MANUFACTURED" (ACUSON-BUILT) ULTRASOUND PROBE RATHER THAN PAY A HIGHER PRICE FOR THE FRENCH-MADE ULTRASOUND PROBE THAT ORIGINALLY ACCOMPANIED THE CYPRESS SYSTEM. THE CYPRESS SYSTEM WAS ORIGNALLY BUILT BY ECTON TO WORK WITH A FRENCH-MADE ULTRASOUND PROBE. DURING THIS INITIAL CONTACT, SIEMENS STATED THAT THEY HAD RECEIVED CALLS FROM OTHER CUSTOMERS WHO HAD SIMILAR PROBLEMS WITH THE NEW UPGRADED SOFTWARE IN OPERATION WITH THE ORIGINAL FRENCH-MADE PROBE. THIS PROBLEM WAS FIXED WHEN AN ACUSON-BUILT PROBE WAS SENT OUT TO REPLACE THE FRENCH-MADE PROBE. THE CO IMMEDIATELY SENT AN ACUSON-BUILT PROBE. WHEN REPORTER SUBSEQUENTLY CALLED SIEMENS AND ASKED WHY THEY WERE NOT MADE AWARE OF THE POTENTIAL PROBLEMS SOONER, SIEMENS STATED THAT THE UPGRADED SOFTWARE WAS COMPATIBLE WITH THE FRENCH-MADE PROBE AND THAT NO OTHER USER HAD COMPLAINED. SIEMENS BLAMED THE PROBLEM ON A MALFUNCTIONING FRENCH-MADE PROBE. THEY REFUSED TO HAVE THE FRENCH-MADE PROBE TESTED BY AN INDEPENDENT COMPANY, SUCH AS THE ORIGINAL FRENCH MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSON CYPRESS ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND SYSTEM ITX ACUSON CORPORATION, NOW OWNED BY SIEMENS CYPRESS SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention