BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON Z6MS ULTRASOUND TRANSDUCER

    MDR report key: 7160298 · Received January 3, 2018

    Report

    Report Number
    3009498591-2018-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 20, 2017
    Report Date
    June 28, 2018
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    ITX
    PMA / PMN Number
    K142628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE SERIAL NUMBER OF THE DEVICE (SEE SECTION D4); UPDATE THE DEVICE AVAILABLE FOR EVALUATION (SEE SECTION D10); PROVIDE THE NEW DATE RECEIVED BY MANUFACTURER (SEE SECTION G4); PROVIDE THE TYPE OF REPORT (SEE SECTION G7); PROVIDE THE TYPE OF REPORTABLE EVENT (SEE SECTION H1); PROVIDE THE TYPE OF FOLLOW-UP (SEE SECTION H2); UPDATE THE DEVICE EVALUATED BY MANUFACTURER (SEE SECTION H3); PROVIDE THE DEVICE MANUFACTURE DATE (SEE SECTION H4); UPDATE THE EVENT PROBLEM AND EVALUATION CODES (SEE SECTION H6); AND PROVIDE THE DEVICE EVALUATION RESULTS (SEE SECTION H10). THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO SIEMENS FOR INVESTIGATION. VISUAL INSPECTION OF THE TRANSDUCER CONFIRMED THE REPORTED ISSUE. INVESTIGATION FOUND THAT THE MONOCOIL WAS NOT ATTACHED TO THE LUG IN THE ARTICULATION SECTION OF THE TRANSDUCER. THE MONOCOIL WAS OBSERVED TO BE DISLOCATED AND CAUSED A KINK OR BEND WHEN GUIDE TUBE IS STRESS PERPENDICULAR TO THE FORCE APPLIED. THE TRANSDUCER WAS SENT TO THE INSTRUMENT TECHNOLOGY INC. (ITI) FOR FURTHER ANALYSIS. MULTIPLE TESTS WERE DONE AT ITI AND THEY REPORTED THAT THERE COULD BE MULTIPLE CAUSES OF THE REPORTED ISSUE. HOWEVER, SINCE THE MONOCOIL DAMAGE LIKELY OCCURRED DURING THE INSERTION PROCESS OF THE CABLE ASSEMBLY (WHEN THE FLEX CIRCUIT WAS STILL THE OLDER LARGER VERSION), ITI CONCLUDED THAT THE CAUSE FOR THE REPORTED ISSUE IS DUE TO THE TIGHT PACKING OF THE FLEX CIRCUIT WHICH RESTRICTS MOTION INSIDE THE CABLE ASSEMBLY. THE FLEX CIRCUIT ISSUE IN THE CABLE ASSEMBLY IS ADDRESSED BY CAPA2017-11000337, WHERE IN THE CORRECTIVE ACTION, THE CABLE BUNDLE DIAMETER WAS DECREASED. ENGINEERS STATED THAT THE FLEX/CABLE PACKAGING COULD STRESS THE PART DURING INSERTION WHICH CAN CAUSE KINKING AND THAT THE NEW FLEX/CABLE PACKAGING (POST-CAPA) HAS SMALLER OUTER DIAMETER AND WILL HELP PREVENT THIS TYPE OF FAILURE. THE CABLE ASSEMBLY DESIGN CHANGED WITH SMALLER CABLE BUNDLE OUTER DIAMETER SINCE JUL. 2017. 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. REFERENCE COMPLAINT # (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT WAS INTUBATED, THE PHYSICIAN HAD A DIFFICULT TIME MANEUVERING THE TRANSDUCER PROBE DURING A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROCEDURE. IT WAS NOTED UNDER FLUOROSCOPY THAT THERE WAS A HARD BEND ON THE PROBE WHICH WAS NOT SEEN BEFORE THE PROCEDURE STARTED. THE PHYSICIAN PULLED OUT THE PROBE AND THEN REINTUBATED THE PATIENT WITH A DIFFERENT BUT SIMILAR TRANSDUCER. THE ULTRASOUND SYSTEM WAS ALSO REPLACED TO CONTINUE AND COMPLETE THE TEE. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4408 ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE ITX SIEMENS MEDICAL SOLUTIONS USA, INC. Z6MS TRANSDUCER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1