BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7322472 · Received March 7, 2018

    Report

    Report Number
    8031673-2018-01233
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    July 25, 2015
    Report Date
    March 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON THE (B)(6) 2015. DURING SERVICE CALL THE FSE NEEDED 5AMP FUSE ON POWER BOARD AND DID NOT HAVE NEWER STYLE ON HAND AND USSED 4 AMP FUSE. BUT FOUND FUSE HAD BLOWN. REPLACED FUSE WITH PROPER 5 AMP AND CLEANED SAMPLER Z-AXIS LEAD SCREW AND ADJUSTED CABLE ROUTING FOR SAMPLER TO MAKE SURE NOTHING CATCHES DURING OPERATION. PERFORMED DAILY STARTUP AND CUSTOMER RAN QUALITY CONTROL (QC) WITHOUT ERRORS. THE PROBABLE CAUSE OF THE EVENT WAS POWER PCB 5A FUSE. 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 THE (B)(6) 2015 THE CUSTOMER REPORTED ERRORS 3001 PRINTER PAPER END ERROR AND 4018 Z AXIS HOME NOT FOUND WITH THEIR AIA 360. THE PROBLEM OCCURRED UPON START UP AND REPORTEDLY DOES NOT INITIALLIZE THE USER PERFORMED SEVERAL STEPS BUT WAS UNABLE TO RECTIFY THE ERROR. CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE REPORTED ISSUE WHICH RESULTED IN DELAY REPORTING OF RESULTS FOR E2, PROG AND LHII. 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
    164381 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability