BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON S2000 ULTRASOUND SYSTEM

    MDR report key: 6126519 · Received November 23, 2016

    Report

    Report Number
    3009498591-2016-00624
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 27, 2016
    Report Date
    February 10, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYO
    PMA / PMN Number
    K140959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE DEVICE AVAILABLE FOR EVALUATION , UPDATE THE FOLLOW-UP TYPE , UPDATE THE DEVICE EVALUATED BY MANUFACTURER , UPDATE THE EVENT PROBLEM AND EVALUATION CODES, AND PROVIDE THE INVESTIGATION RESULTS. INVESTIGATION: THE FRAYED CABLES CAN BE CAUSED BY TWO DIFFERENT CASES: SYSTEM IS MOVED WITHOUT UNPLUGGING THE SYSTEM FROM THE WALL. THIS PUTS UNDUE FORCE ON THE CABLE. THIS HAS BEEN SEEN TO CAUSE DAMAGE AT EITHER THE SYSTEM END OR THE WALL END OF THE CABLE. SYSTEM IS BUMPED INTO THE WALL SUCH THAT THIS CABLE CONNECTION HITS THE WALL AND DAMAGES THE CABLE. THE INTERIM SOLUTION IS TO REPLACE ANY CABLE WHERE FRAYING IS OBSERVED. THE LONG TERM IMPROVEMENT TO THE RELIABILITY OF THIS CABLE IS BEING INVESTIGATED. THIS INVOLVES A DESIGN CHANGE TO A RIGHT ANGLE PLUG THAT CAN REDUCE THE LIKELIHOOD OF DAMAGE FROM STRIKING THE WALL. THIS COULD NOT BE EXPECTED TO GUARD FROM ALL FORMS OF DAMAGE, BUT WOULD BE EXPECTED TO REDUCE THE FREQUENCY OF THIS TYPE OF EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SIEMENS FOR EVALUATION; THEREFORE, THE INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED AND THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ELECTRICAL SAFETY CHECK, THE LOCAL SITE QUALITY ASSURANCE (QA) HAD NOTED THAT THE SYSTEM MAINS CABLE HAD SPLIT WHERE THE IEC CONNECTION MEETS THE CABLE. THE DEVICE WAS NOT BEING USED TO TREAT OR DIAGNOSE A PATIENT WHEN THE REPORTED PHENOMENON WAS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774387 ACUSON S2000 ULTRASOUND SYSTEM ULTRASOUND DEVICE IYO SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1