BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUSON S2000 ULTRASOUND SYSTEM

    MDR report key: 5603662 · Received April 25, 2016

    Report

    Report Number
    3009498591-2016-00081
    Event Type
    Other
    Date Received
    April 25, 2016
    Date of Event
    March 28, 2016
    Report Date
    February 7, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K140959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WHICH IS BEING RE-SUBMITTED PER FDA'S REQUEST AS THE ORIGINAL SUPPLEMENTAL MDR (MFR#3009498591-2016-00081) SUBMITTED IN 2016 DID NOT GO THROUGH CORRECTLY. CORRECTION: CORRECT THE BRAND NAME OF THE DEVICE (SEE SECTION D1), UPDATE THE DEVICE AVAILABLE FOR EVALUATION (SEE SECTION D10), UPDATE/CORRECT THE INITIAL REPORTER INFORMATION (SEE SECTION E1,E2,E3), ADDITIONAL INFORMATION:ADDITIONAL EVENT INFORMATION (SEE SECTION B5), UPDATE THE MANUFACTURER'S CONTACT INFORMATION (SEE SECTION G1), PROVIDE THE DATE RECEIVED BY MANUFACTURER (SEE SECTION G4), PROVIDE THE PMA/510(K) INFORMATION (SEE SECTION G5), PROVIDE THE TYPE OF REPORTABLE EVENT (SEE SECTION H1), UPDATE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3), PROVIDE THE EVENT PROBLEM AND EVALUATION CODES (SEE SECTION H6), PROVIDE ADDITIONAL MANUFACTURER NARRATIVE (SEE SECTION H10). THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; THEREFORE, THE INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. THE SAVELOGS WERE RETRIEVED AND REVIEWED AND IT WAS FOUND THAT THE REPORTED MISSING IMAGES MAY HAVE BEEN INADVERTENTLY DELETED BY THE USER.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE DEVICE AVAILABLE FOR EVALUATION (SEE D10), UPDATE THE FOLLOW-UP TYPE (SEE H2), UPDATE THE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3), AND UPDATE THE EVENT PROBLEM AND EVALUATION CODES (SEE H6) ON H6), AND PROVIDE THE INVESTIGATION RESULTS. DURING INVESTIGAITON OF THIS ISSUE, HEADQUARTER SUPPORT CENTER REVIEWED THE LOGGING CONCURRENT WITH THE EVENT AS PART OF THE INITIAL CLARIFICATION ACTIVITY. THE "MISSING" IMAGES CAN BE ACCOUNTED FOR WITH THE DELETE JOB COMPLETED. THIS IS A CASE OF THE USER SELECTING MULTIPLE IMAGES TO DELETE AT THE STUDY CLOSE WHILE IN THE REVIEW PAGE. WHEN AN IMAGE IS SELECTED FOR DELETION, THERE IS A LARGE RED "X" COVERING THE IMAGE THUMBNAIL PRIOR TO STUDY CLOSE. THE MOST PROBABLE CAUSE WAS DUE TO USER ERROR.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT WHICH IS BEING RE-SUBMITTED PER FDA'S REQUEST AS THE ORIGINAL SUPPLEMENTAL MDR (MFR#3009498591-2016-00081) SUBMITTED IN 2016 DID NOT GO THROUGH CORRECTLY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT DURING A DUPLEX HEMODIALYSIS ACCESS STUDY, THE SONOGRAPHER NOTICED THAT THE IMAGES WERE MISSING BEFORE SELECTING THE END EXAM BUTTON. IT WAS REPORTED THAT THE LOST IMAGES WERE UNRECOVERABLE BUT THE STUDY WAS NOT REPEATED. THE STUDY ITSELF WITHOUT THE IMAGES WERE REPORTED TO HAVE BEEN ARCHIVED TO COMPACT DISC FOR FURTHER ANYALYSIS. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDERGOING AN EVALUATION BUT HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ALLEGED CLAIM OF LOST DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259919 ACUSON S2000 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown