BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON 18L6 HD ULTRASOUND TRANSDUCER

    MDR report key: 6602457 · Received May 31, 2017

    Report

    Report Number
    3009498591-2017-00098
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    September 1, 2016
    Report Date
    October 27, 2021
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    ITX
    PMA / PMN Number
    K142628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL SUBMISSION NARRATIVE: THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO SIEMENS FOR EVALUATION. IT WAS FOUND DURING DESTRUCTIVE ANALYSIS THAT WHEN TOUCHING THE FLEX WHICH IS CONNECTED TO THE AMB A-BOARD, THE NOISE WAS DETECTED IN C-MODE. THE TRANSDUCER WAS INVESTIGATED AND THE LIKELY ROOT CAUSE OF THE REPORTED PHENOMENON IS DUE TO ELECTRICAL SHORT DUE TO CONTACT FAILURE BETWEEN ARRAY FPCB AND AMB. BASED ON THE INVESTIGATION RESULT, TRIPLE IMAGES CAN BE CAUSED BY ELECTRICAL SHORT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THERE IS NO INFORMATION TO INDICATE ANY NON-CONFORMANCE AT THE TIME OF MANUFACTURING PROCESS. (B)(4). 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

    DURING A RETROSPECTIVE REVIEW OF SERVICE NOTIFICATIONS, IT WAS FOUND THAT DURING AN UNSPECIFIED STUDY, THE 18L6 HD TRANSDUCER GENERATED TRIPLE IMAGE ARTIFACTS. THE REPORTED PATIENT OUTCOME WAS DELAY OF DIAGNOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381172 ACUSON 18L6 HD ULTRASOUND TRANSDUCER ULTRASOUND DEVICE ITX SIEMENS MEDICAL SOLUTIONS USA, INC. 18L6 HD TRANSDUCER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown