BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7963724 · Received October 13, 2018

    Report

    Report Number
    8031673-2018-00926
    Event Type
    Malfunction
    Date Received
    October 13, 2018
    Date of Event
    September 23, 2018
    Report Date
    October 13, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER TO ADDRESS THE REPORTED ISSUE. DURING SERVICING, FSE CONFIRMED THE ERROR WHEN OBSERVING THE CUP TRANSFER MACRO RUN. FSE PERFORMED TROUBLESHOOTING BY CHECKING THE VOLTAGE FOR THE CUP Z MOTOR. THE VOLTAGE WAS AT 4.23V, WHICH WAS WITHIN SPECIFICATIONS. FSE RESOLVED THE COMPLAINT BY REPLACING THE Z-AXIS MOTOR AND PERFORMED ALL CUP TRANSFER ALIGNMENTS. FSE RAN THE CUP TRANSFER MACRO FOUR TIMES WITHOUT ANY ISSUES. QUALITY CONTROLS WERE RUN WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS OPERATING AS EXPECTED. THERE WAS NO FURTHER ACTION REQUIRED BY FSE. THE Z-AXIS MOTOR WAS RETURNED FOR EVALUATION. THE INSTRUMENT WAS FUNCTIONALLY TESTED AND WAS FOUND TO HAVE GOOD OHM CONTINUITY ON BOTH FIELD COILS. HOWEVER, DURING VISUAL INSPECTION, THE SHAFT OF THE MOTOR WAS PHYSICALLY TURNED AND TWO "HARD" SPOTS WERE FOUND APPROXIMATELY 30 DEGREES APART. THIS INDICATED A DEFECTIVE GEAR REDUCER. THE PART FAILED TO MEET VISUAL INSPECTION. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 23-AUG-2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS FOUND DURING THE SEARCHED PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER SECTION 12 - FLAGS AND ERROR MESSAGES STATES THE FOLLOWING: [4151] C.TRANS-Z HOME DETECT ERROR CAUSE: THE HOME SENSOR S062 FAILED TO BE ACTIVATED AFTER THE TRANSFER Y MOVED TOWARD THE HOME POSITION. A RETRY WILL TAKE PLACE, AND IF THERE IS NO IMPROVEMENT A MF FLAG WILL BE ATTACHED TO THE MEASUREMENT RESULT. ACTION: PLEASE CONTACT TOSOH LOCAL REPRESENTATIVES. CHECK S062 AND PM061 FOR A POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE OF THE 4151 C-TRANS Z-HOME DETECT ERROR WAS DUE TO FAILURE OF THE Z-AXIS MOTOR.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED ERROR 4151 C TRANS-Z HOME DETECT MESSAGES WITH THE AIA-900 INSTRUMENT. THE CUSTOMER PERFORMED AN ALL SET HOME AND THE ERROR REOCCURRED. TECHNICAL SUPPORT SPECIALIST (TSS) INSTRUCTED THE CUSTOMER TO OBSERVE IF THE CUP TRANSFER MECHANISM WAS STOPPED OVER THE INCUBATOR. THE CUSTOMER CLEANED UP THE CUP TRANSFER AND REPOWERED THE INSTRUMENT ON BUT THE ERROR REOCCURRED. THE INSTRUMENT WAS DOWN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF LUTENIZINE HORMONE (LHII), FOLLICLE STIMULATING HORMONE (FSH), AND BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804002 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1