BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA 2000

    MDR report key: 7326741 · Received March 9, 2018

    Report

    Report Number
    8031673-2018-02129
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    October 25, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2016, A FIELD SERVICE ENGINEER (FSE) CLEANED OUT ALL DROPPED CUPS FROM INSTRUMENT AND SORTER, REPLACED SLAVE BOARD, AND PERFORMED VERSION UP TO RELOAD BOARD SOFTWARE. ALL SORTER ALIGNMENTS WERE CHECKED. THE CUSTOMER PERFORMED DAILY STARTUP AND RAN CUSTOMER QUALITY CONTROLS (QC) AND ALL WERE WITHIN RANGE. THE AIA-2000 WAS FUNCTIONING AS INTENDED. NO FURTHER ACTION REQUIRED FROM FILED SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS A SLV BOARD FAILURE. 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 ERROR 4041 SORTER Y AXIS HOME DETECTION FAILURE ON THE AIA-2000ST 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170812 AIA 2000 AIA 2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1