BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON Z6MS ULTRASOUND TRANSDUCER

    MDR report key: 6602954 · Received May 31, 2017

    Report

    Report Number
    3009498591-2017-00217
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 15, 2017
    Report Date
    June 19, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    ITX
    PMA / PMN Number
    K142628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO SIEMENS FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE DEVICE AVAILABLE FOR EVALUATION , PROVIDE THE DATE RECEIVED BY MANUFACTURER , UPDATE DEVICE EVALUATED BY MANUFACTURER , PROVIDE THE DEVICE MANUFACTURE DATE , UPDATE THE EVENT PROBLEM AND EVALUATION CODES , AND PROVIDE THE DEVICE INVESTIGATIONAL RESULTS. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED FOR EVALUATION. ENGINEERING INVESTIGATED THE ISSUE AND FOUND THROUGH ACOUSTIC TESTING THAT THERE WAS NO SYSTEM ERROR BUT THE TEST FAILED. THE CABLE SHORT (MBUSCLK2+ TO GRD, MBUSCLK4- TO GRD, MBUSCLK6+ TO GRD) CONFIRMED THROUGH DESTRUCTIVE ANALYSIS. THUS, THE POSSIBLE ROOT CAUSE WAS DETERMINED AS RAW CABLE KINK AND COAX SHEATH WORN OUT DURING BENT AND TWISTED BECAUSE OF MANUFACTURING PROCESS VARIANCE AND/OR INSUFFICIENT CABLE MECHANICAL RELIABILITY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR AND THE STAFF WERE SETTING UP THE TRANSDUCER IN PREPARATION FOR A HEART EXAM WHEN THE SYSTEM FROZE AND THE TRANSDUCER DISPLAYED A USACQUISITIONHW_40 ERROR MESSAGE. THE PATIENT WAS ALREADY SEDATED AND ON THE TABLE. THE DOCTOR REBOOTED THE SYSTEM TO RESTORE FUNCTIONALITY BUT USED ANOTHER TRANSDUCER TO CONTINUE AND COMPLETE THE INTENDED EXAM. THERE WAS A DELAY OF 15-20 MINUTES WHILE THE REPLACEMENT TRANSDUCER WAS OBTAINED. THERE WAS NO LOSS OF DATA AND THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382654 ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE ITX SIEMENS MEDICAL SOLUTIONS USA, INC. Z6MS TRANSDUCER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1