BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7368783 · Received March 25, 2018

    Report

    Report Number
    8031673-2018-03000
    Event Type
    Malfunction
    Date Received
    March 25, 2018
    Date of Event
    June 7, 2017
    Report Date
    March 25, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 7 JUNE 2017. THE FSE INSPECTED THE CUP TRANSFER UNIT AND PRESENCE SENSOR AND NOTED NO ISSUES. THE ENGINEER PERFORMED CUP TRANSFER TESTS WHICH SHOWED MISALIGNMENT WHEN PLACING THE CUP ONTO D-LANE. THE FSE CHECKED AND ADJUSTED ALIGNMENTS FOR D-LANE AND INNER AND OUTER INCUBATOR POSITIONS, THEN PERFORMED SORTER TEST AND REPORTED NO ISSUES. THE ENGINEER PERFORMED CUP TRANSFER TESTS MULTIPLE TIMES WITH NO ISSUES. THE AIA-900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS THE CUP TRANSFER ALIGNMENT

    Description of Event or Problem · 0

    ON (B)(6) 2017 A CUSTOMER REPORTED ERROR 2160 C TRANS CUP NOT DETECTED WITH THEIR AIA-900 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING IPTH AND PRL PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211544 AIA-900 AIA-900, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1