BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7391078 · Received April 2, 2018

    Report

    Report Number
    8031673-2018-03033
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    November 18, 2016
    Report Date
    April 2, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18-NOV-2016, AN FSE CONDUCTED ON-SITE FOLLOW-UP WITH THE CUSTOMER. THE FSE OBSERVED THAT THE BELT POSSIBLY SKIPPED A TOOTH. THE FSE MADE THE BELT ADJUSTMENTS, CHECKED ALIGNMENTS, TIGHTENED THE BELTS FOR THE INCUBATOR, PERFORMED VOLTAGE ADJUSTMENT ON Z-CUP TRANSFER AND RETURNED THE INSTRUMENT TO NORMAL OPERATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO DEFECTIVE INCUBATOR ALIGNMENT. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED A C TRANSFER HOME OVERRUN WITH THEIR AIA-900 ANALYZER. THE CUSTOMER IS UNABLE TO RUN BHCG, FSH, LHII, PROG, AND E2PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED EVENT. THERE IS 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
    231902 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1