BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z6MS TRANSDUCER

    MDR report key: 19845245 · Received July 26, 2024

    Report

    Report Number
    3023245-2024-00046
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    April 27, 2024
    Report Date
    January 29, 2025
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR (MFR# 3023245-2024-00046) WAS SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS. THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INVESTIGATION RESULTS. IN THIS CASE, SERVICE ARRIVED AT THE SITE AND COULD NOT REPRODUCE THE ISSUE. BASED ON THE INVESTIGATION, IT WAS RECOMMENDED TO REPLACE THE CONTROL KNOB KIT AS A PRECAUTIONARY MEASURE. HOWEVER, THE CUSTOMER SAID THEY SINCE THE TRANSDUCER WAS WORKING AS EXPECTED AND THE ISSUE DID NOT RECUR, THEY DID NOT WANT TO REPLACE THE CONTROL KNOB. ACCORDING TO USER THEY WERE EVENTUALLY ABLE TO GET THE TIP IN "ZERO" POSITION. IF THE ISSUE RECURS, THEY WOULD CONTACT SIEMENS SERVICE. A SEARCH WAS PERFORMED IN THE SERVICE AND COMPLAINTS DATABASE (GSMS AND SMARTSOLVE) AND NO OTHER RELATED ISSUES WERE FOUND FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    CUSTOMER STATED THAT THE DISTAL TIP ON HIS Z6MS LOCKED ITSELF IN A DEFLECTED POSITION DURING A PROCEDURE. UNCLEAR HOW HE RECOVERED FROM THAT. WHEN CSE INSPECTED THE PROBE, ALL WAS WORKING WELL. THIS MDR IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883619 Z6MS TRANSDUCER ULTRASOUND TRANSDUCER ITX SIEMENS HEALTHINEERS 10436113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown