BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, SWIFTLINK, P500, 64 CH.

    MDR report key: 21298327 · Received February 3, 2025

    Report

    Report Number
    3023245-2025-00032
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    April 7, 2022
    Report Date
    February 3, 2025
    Manufacturer
    SIEMENS HEALTHINEERS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. INVESTIGATION WAS COMPLETED AND IT WAS FOUND THAT THE PART WAS NOT RETURNED. THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE IDENTIFIED. REFERENCE # (B)(4).

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE, THERE WAS A SWIFT LINK RECOGNITION ISSUE. THE CATHETER PROBE IS RECOGNIZED AT THE TIME OF CARTO; BUT WHEN IT ENTERS THE BODY, THE PROBE DISCONNECTS AND IS NOT RECOGNIZED. THE PROBE WAS INSERTED AND THEN REMOVED FROM THE PATIENT. THE CUSTOMER CANCELED THE EXAM AND RESCHEDULED IT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039917 ASSY, SWIFTLINK, P500, 64 CH. ULTRASOUND TRANSDUCER ITX SIEMENS HEALTHINEERS 11147292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization