BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7315722 · Received March 6, 2018

    Report

    Report Number
    8031673-2018-01739
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    May 21, 2016
    Report Date
    March 6, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO INSPECTED THE ALIGNMENT OF THE WASTE SHOOT. IT SHOWED THAT THE BOTTOM SHOOT WAS MISALIGNED THAT ALLOWED THE TIPS TO GET STUCK BETWEEN THE MIDDLE AND BOTTOM SHOOT. FSE REMOVED ALL THE SHOOT AND VERIFIED THAT TECH BULLETIN AIA-900-T066(E) WAS ALREADY INSTALLED. FSE ALSO CLEANED ALL THE SHOOTS AND REINSTALLED THEM CORRECTLY. CUSTOMER CALIBRATED INSTRUMENT . VERIFIED INSTRUMENT OPERATION. NO FURTHER ACTIONS IS REQUIRED BY THE FSE THE PROBABLE CAUSE OF THE EVENT WAS WASTE SHOOT ISSUE. 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 (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED ERROR 4153 (C TRANS HOME OVERRUN) WITH THEIR AIA-900 ANALYZER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2016 TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR CTNL2 PATIENT RESULT. 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
    161787 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1