BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA 2000

    MDR report key: 7327926 · Received March 9, 2018

    Report

    Report Number
    8031673-2018-02133
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    November 7, 2016
    Report Date
    March 9, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016, THE FSE WAS DISPATCHED AND VERIFIED DATA TRANSMISSION FROM AIA-2000 TO LAPTOP USING HYPERTERMINAL PROGRAM. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS UNKNOWN, ANALYZER IS SENDING RESULTS. THE PROBABLE CAUSE OF THE EVENT WAS THE WASTE FUNNEL CLOGGED. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH TCORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2016, A CUSTOMER REPORTED ON THE AIA-2000ST THAT THE 2000 IS NOT SENDING DATA TO THE MED X AND THEY CANNOT TROUBLESHOOT IT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS. 3005 LEAK SENSOR BF WASH PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169709 AIA 2000 AIA 2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1