BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7366847 · Received March 23, 2018

    Report

    Report Number
    8031673-2018-03408
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    May 4, 2016
    Report Date
    March 23, 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

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO FOUND DRIED WASH LUMP ON S702 PCB WIRE CONTACTS INTERMITENTLY SHORTING SENSOR AND CAUSING ERROR. FSE REMOVED THE SENSOR AND CLEANED CONTACTS AND SENSOR. NO LEAK FOUND .CUSTOMER RAN CONTROLS WHICH WERE WITHIN RANGE.NO FURTHER ACTION REQUIRED BY FIELD SERVICE THE PROBABLE CAUSE OF THE EVENT WAS LEAKING SENSOR 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) 2016 A CUSTOMER REPORTED A LEAK SENSOR ERROR WITH THEIR AIA 360 ANALYZER.A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2016, THE CUSTOMER TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS PTH. 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
    208754 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1