BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 7764579 · Received August 8, 2018

    Report

    Report Number
    8031673-2018-00773
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    August 2, 2018
    Report Date
    August 8, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED ERRORS. FSE FOUND THE Y-AXIS CUP TRANSFER ALIGNMENTS WERE OFF. THE FSE RE-ALIGNED ALL Y-AXIS TRANSFER POINTS AND RAN CUP TRANSFER EVALUATION MULTIPLE TIMES WITHOUT ANY ERRORS. CUSTOMER RAN MULTIPLE SPECIMEN TEST AND NO ERRORS WERE REPORTED. THE INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELEASED. NO FURTHER ACTIONS ARE REQUIRED BY THE FSE. A COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM THE (B)(6) 2017 THROUGH AWARENESS DATE ON THE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER A4, APPENDIX 4: ERROR MESSAGE STATES THE FOLLOWING: ERROR MESSAGES: 4183 Y-AXIS CUP TRANSFER Y-AXIS HOME OVERRUN- CAUSE: THE HOME SENSOR ACTIVATED IMPROPERLY AFTER MOVEMENT OF THE Y-AXIS CUP TRANSFER Y-AXIS. IF THIS OCCURS, THE CURRENT MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG) AND NEW MEASUREMENTS WILL BE SUSPENDED. SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE WAS DUE TO Y-AXIS ALIGNMENTS. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING ERROR 4183 Y-AXIS CUP TRANSFER Y-AXIS HOME OVERRUN FAILURE ON THEIR AIA-2000 INSTRUMENT AFTER A PREVENTATIVE MAINTENANCE WAS PERFORMED. THE CUSTOMER POWERED THE INSTRUMENT OFF THEN TURNED IT BACK ON BUT THE ERROR STILL OCCURRED. CUSTOMER REPORTED INSTRUMENT IS DOWN. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF LH II AND CTNI2 PATIENT RESULTS. 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
    602164 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1