BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, SWIFTLINK, P500, 64 CH.

    MDR report key: 19617895 · Received June 26, 2024

    Report

    Report Number
    3023245-2024-00034
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 17, 2024
    Report Date
    June 26, 2024
    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

    AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE# (B)(4).

    Description of Event or Problem · 0

    THE ACUSON P500 SYSTEM WAS HAVING TRANSDUCER RECOGNITION DISORDERS WITH THE SWIFTLINK AND NO IMAGE WAS DISPLAYED. THE PATIENT WAS SEDATED AT THE TIME. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550587 ASSY, SWIFTLINK, P500, 64 CH. ULTRASOUND TRANSDUCER ITX SIEMENS HEALTHINEERS 11147292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization