BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON Z6MS ULTRASOUND TRANSDUCER

    MDR report key: 6603309 · Received May 31, 2017

    Report

    Report Number
    3009498591-2017-00231
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 11, 2017
    Report Date
    June 16, 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 PROVIDE ADDITIONAL MANUFACTURER NARRATIVE. ENGINEERING INVESTIGATED THE ISSUE AND FOUND THAT THERE WAS NO SYSTEM ERROR BUT THE ACOUSTIC TEST FAILED. CABLE SHORT (MBUSCLK1- TO GRD, VTGC+ TO GRD) WAS CONFIRMED THROUGH DESTRUCTIVE ANALYSIS. THUS, THE POSSIBLE ROOT CAUSE WAS IDENTIFIED AS RAW CABLE KINK AND COAX SHEATH WORN OUT DURING BENT AND TWISTED BECAUSE OF MANUFACTURING PROCESS VARIANCE AND/OR INSUFFICIENT CABLE MECHANICAL RELIABILITY. THE CABLE ASSEMBLY DESIGN AND MANUFACTURING PROCESS HAVE BEEN REVIEWED BY RELEVANT ENGINEERING GROUPS. CABLE ASS'Y MANUFACTURER (SUMITOMO) HAS CHANGED THE PROCESS (TWINAX BUNDLE METHOD) THROUGH SECR (B)(4) AND CAPA (B)(4). IT HAS BEEN IMPLEMENTED TO Z6MS TRANSDUCERS SINCE MAY. 22ND, 2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ALREADY SEDATED AND ON THE TABLE UNDERGOING A HEART EXAM, IN THE MIDDLE OF THE EXAM, THE PHYSICIAN TESTED THE PATIENT'S HEART FUNCTION BY CHECKING THE ULTRASOUND IMAGING. HOWEVER, THE SYSTEM DID NOT DISPLAY THE IMAGE IN COLOR. THE PHYSICIAN DID NOT REBOOT THE SYSTEM BUT REMOVED THE TRANSDUCER AND USED A NEW TRANSDUCER TO CONTINUE AND COMPLETE THE EXAM. THERE WAS A DELAY OF 15 MINUTES WHILE THE REPLACEMENT TRANSDUCER WAS RETRIEVED. 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
    382098 ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE ITX SIEMENS MEDICAL SOLUTIONS USA, INC. Z6MS TRANSDUCER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1