BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON S2000 ULTRASOUND SYSTEM

    MDR report key: 6049404 · Received October 21, 2016

    Report

    Report Number
    3009498591-2016-00482
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    August 22, 2016
    Report Date
    October 21, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K111674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDERGOING AN EVALUATION, BUT HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    AS A RESULT OF A RECENT FDA INSPECTION, WE ARE RETROSPECTIVELY REVIEWING COMPLAINTS AND ASSOCIATED DOCUMENTS FOR COMPLIANCE TO THE REGULATIONS FROM 2015 TO DATE. WE HAVE STRENGTHENED OUR MDR REPORTING CRITERIA AND WE ARE REPORTING THE ATTACHED MEDICAL DEVICE REPORT IN ACCORDANCE WITH OUR NEW CRITERIA. AS A RESULT OF THIS RETROSPECTIVE REVIEW, THIS MDR IS BEING REPORTED IMMEDIATELY UPON DISCOVERY. V5M TRANSDUCERS RECEIVING OVER-TEMPERATURE WARNING REQUIRING DISCONNECTING/RECONNECTING THE TRANSDUCER TO RESET SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699064 ACUSON S2000 ULTRASOUND SYSTEM DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000

    Patients

    Seq Age Sex Outcome Treatment
    1