BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON S2000 ULTRASOUND SYSTEM

    MDR report key: 6395437 · Received March 10, 2017

    Report

    Report Number
    3009498591-2016-00273
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    August 24, 2015
    Report Date
    October 11, 2021
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYO
    PMA / PMN Number
    K140959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE. NOTE: THE ORIGINAL EMDR WAS SUBMITTED TO THE NON-PRODUCTION ENVIRONMENT. THIS REPORT IS TO SUBMIT TO THE PRODUCTION ENVIRONMENT.

    Description of Event or Problem · 0

    AS A RESULT OF A RECENT FDA INSPECTION, WE ARE RETROSPECTIVELY REVIEWING COMPLAINTS AND ASSOCIATED DOCUMENTS FOR COMPLIANCE TO THE REGULATIONS FROM 2015 TO DATE. WE HAVE STRENGTHENED OUR MDR REPORTING CRITERIA AND WE ARE REPORTING THE ATTACHED MEDICAL DEVICE REPORT IN ACCORDANCE WITH OUR NEW CRITERIA. AS A RESULT OF THIS RETROSPECTIVE REVIEW, THIS MDR IS BEING REPORTED IMMEDIATELY UPON DISCOVERY. SIEMENS MEDICAL SOLUTIONS USA, INC. RECEIVED A MEDWATCH REPORT # (B)(4) REPORTING THE FOLLOWING: " AS THE ULTRASOUND TECH WAS PERFORMING THE ULTRASOUND AND THE MACHINE SHUT OFF DURING THE EXAM. THE ULTRASOUND HAD TO BE UNPLUGGED FROM THE POWER CORD IN ORDER TO SHUT IT OFF AND BE ABLE TO TURN IT BACK ON TO CONTINUE THE CASE. THIS SAME SCENARIO HAS HAPPENED 3 TIMES IN THE LAST 2 DAYS AND WE ARE WAITING FOR THE MANUFACTURER TO COME OUT TODAY TO ASSES THE PROBLEM. THEY ALSO HAD REPLACED THE HARD DRIVE IN THIS UNIT ON (B)(6) 2015, BECAUSE THE MACHINE WOULD NOT BOOT UP." SIEMENS FOLLOWED UP WITH THE EVENT REPORTER AT THE USER FACILITY AND IT WAS REPORTED THAT THE ISSUE HAPPENED ON MULTIPLE PATIENTS. THE USER FACILITY BELIEVES THAT THE CAUSE IS DUE TO EQUIPMENT ISSUE THAT ALSO CONTRIBUTED TO DELAYED PATIENT CARE. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176470 ACUSON S2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE IYO SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown