BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERAL ELECTRIC

    MDR report key: 565651 · Received December 29, 2004

    Report

    Report Number
    MW1034184
    Event Type
    Other
    Date Received
    December 29, 2004
    Date of Event
    November 17, 2004
    Report Date
    December 28, 2004
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    ITX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BECAUSE THE REPORTED PROBLEM IS THAT IMAGES ARE LOST FROM BOTH THE VIVID 7 ULTRASOUND SYSTEM AND THE IMAGE VAULT ARCHIVE AND BECAUSE THE INVESTIGATION HAS YIELDED NO OBVIOUS MALFUNCTION AND THAT THE PROBLEM COULD NOT BE DUPLICATED, THERE REMAINS THE PROBABLE EXPLANATION THAT THIS PROBLEM IS DUE TO USER ERROR. THE TWO MOST LIKELY EXPLANATIONS FOLLOW. BASED ON AVAILABLE INFORMATION, IT APPEARS AN UNFINISHED EXAM WITHOUT IMAGES WAS TRANSMITTED TO IMAGE VAULT. LATER THE SAME DAY, THIS EXAM WAS OPENED ON VIVID 7 AND CONTINUED BY ADDING IMAGES. THE EXAM, NOW WITH IMAGES, WAS STORED ON THE VIVID 7 AND TRANSMITTED TO IMAGEVAULT. THIS TRANSFER WOULD FAIL BECAUSE THIS VERSION SOFTWARE DID NOT INCLUDE AN EXAM REPLACE FUNCTION. AN ERROR MESSAGE "INFORMATION: SOME OR ALL PATIENTS FAILED DURING COPY X OF Y (FOR INSTANCE 1 OF 1) NOT PROPERLY COPIED." WILL DISPLAY AND THE USER WOULD NEED TO PRESS THE OK BUTTON TO PROCEED. THE FAILED TRANSFER STATUS IS LISTED AS "PATIENT ALREADY EXISTS". ASSUMING THE EXAM TRANSFER WAS SUCCESSFUL, THE OPERATOR DELETED IT FROM VIVID 7 RESULTING 38 IMAGES LOST IMAGES. THE OPERATOR COULD HAVE AVOIDED THE PROBLEM BY CHANGING THE DATAFLOW TO THE IMAGE VAULT REMOTE ARCHIVE, THEN OPEN AND DELETING THE EARLIER EMPTY EXAM, CHANGE THE DATAFLOW BACK TO LOCAL ARCHIVE AND THEN RETRANSMIT THE EXAM TO THE IMAGE VAULT. THIS SCENARIO SUPPORTS POTENTIAL CAUSE NO. 2. A LESS LIKELY SCENARIO, SUPPORTING POTENTIAL CAUSE NO. 1, IS THAT THE DELETE BUTTON WAS PRESSED WHILE REVIEWING IMAGES ON VIVID 7 WITHOUT ANY IMAGE SELECTED. THIS WILL CAUSE ALL IMAGES TO BE SELECTED FOR DELETION ALONG WITH DISPLAYING THE DIALOG BOX "ARE YOU SURE YOU WANT TO DELETE ALL SELECTED IMAGES? (38 IMAGES SELECTED)" FOR WHICH THE USER MUST SELECT YES OR NO TO GO ON. IF YES IS SELECTED, THEN THE IMAGES ARE DELETED AND CANNOT BE TRANSMITTED TO IMAGE VAULT. OTHER DATA LIKE MEASUREMENTS WILL BE TRANSFERRED AND THE PROCESS WILL COMPLETE NORMALLY WITH NO ERROR INDICATION. BECAUSE NO PROOF OR OBJECTIVE INDICATIONS TO THE ROOT CAUSE CAN BE DETERMINED AT THIS TIME, THIS INVESTIGATION WILL CONTINUE BY CLOSE MONITORING FOR ADDITIONAL OR SIMILAR EVENTS. IN THE INTERIM, APPROPRIATE PREVENTIVE ACTION IN THE FORM OF ADDITIONAL TRAINING TO ADDRESS THE ABOVE SCENARIOS WILL BE GIVEN FOR THIS SITE DUE THEIR WORKFLOW PROCESS.

    Description of Event or Problem · 1

    UPON COMPLETION OF PT EXAM, EXPORTED EXAM TO THE REMOTE ARCHIVE (ECHO PAC WORK STATION). WHEN PHYSICIAN TRIED TO PULL UP EXAM, NO IMAGES HAD TRANSFERRED, ONLY MEASUREMENTS WERE SEEN. LOCAL ARCHIVE DID NOT CONTAIN IMAGES AS WELL. MANUFACTURER NOTIFIED. MANUFACTURER EVALUATING. UNABLE TO DETERMINE IF EQUIPMENT MALFUNCTION OR USER ERROR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC VIVID 7 EXPERT 110V ULTRASOUND ITX GE MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other