BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA 2000

    MDR report key: 7470945 · Received April 27, 2018

    Report

    Report Number
    3005529799-2018-00360
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    March 30, 2018
    Report Date
    April 27, 2018
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: ON 09-APR-2018, A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER'S SITE TO RESOLVE REPORTED EVENT. FSE INSPECTED INSTRUMENT AND REPLACED THE MAIN BOARD, CLEANED ALL SLAVE AND PULSE MOTOR DRIVER (PMD) BOARD CONNECTORS. FSE VERIFIED ALL POWER SUPPLY VOLTAGES, PERFORMED ALL MAXIA MECHANICAL AND SOFTWARE ADJUSTMENTS, REALIGNED ALL BF ASSY. FSE RECONFIGURED TOWER STYLE DELL COMPUTER IN ENGLISH AND RELOADED VER. 2.05 SOFTWARE. FSE PERFORMED TEMPERATURE ADJUSTMENTS AND SUCCESSFULLY RAN DAILY CHECK. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. A (B)(6) COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH AWARE DATE (B)(6) 2018. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA-2000 SERVICE MANUAL UNDER SECTION 7. ELECTRONICS, STATES THE FOLLOWING MAIN BOARD: EXCEPT FOR SOME OF THE DIRECT WIRING OF THE DIO FROM THE SLV BOARD (ODD-NUMBERED CPU SIDE) AND A/D INPUT, DISTRIBUTION AND RELAY OF ALL SIGNALS FROM THE SLV BOARD TO THE PMD BOARD, OR TO EACH UNIT, IS HANDLED BY THE MAIN BOARD. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE DAMAGED MAIN BOARD.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A CUSTOMER REPORTED A FAILED MAIN BOARD DUE TO WATER DAMAGE FROM STORM ON THE AIA 2000 INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), PROLACTIN (PRL), ESTRADIOL (E2) AND PROGESTERONE (PROG II). THERE IS 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
    311101 AIA 2000 AIA 2000 KHO TOSOH BIOSCIENCE, INC. AIA 2000

    Patients

    Seq Age Sex Outcome Treatment
    1