BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7847912 · Received September 5, 2018

    Report

    Report Number
    8031673-2018-00784
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 5, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. FSE FOLLOWED UP WITH THE CUSTOMER OVER THE PHONE TO ADDRESS THE REPORTED EVENT. INSPECTION OF THE DEVICE BY THE CUSTOMER REVEALED THAT THE WASH PROBE SENSOR WAS DIRTY. FSE INSTRUCTED THE CUSTOMER TO CLEAN THE SENSOR WITH AIR WHICH RESOLVED THE ISSUE. NO FURTHER ISSUES WERE NOTED. NO FURTHER ACTION WAS REQUIRED BY FIELD SERVICE. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THERE WERE TWO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-900 OPERATOR'S MANUAL UNDER CHAPTER 12 - FLAGS AND ERROR MESSAGES WAS REVIEWED. THE 4337 WASH Y POSITIONING OVERRUN ERROR: THE AIA-900 SERVICE MANUAL REVISION B, CHAPTER 8 INDICATES THAT THE 4337 WASH Y POSITIONING OVERRUN ERROR MESSAGE IS GENERATED WHEN THE HOME SENSOR S135 IS ACTIVATED PRIOR TO A POINT CORRESPONDING TO 40 PULSES BEFORE THE END OF THE DISTANCE THROUGH WHICH THE INCUBATOR IS SUPPOSED TO MOVE. THE MEASUREMENT WILL BE INTERRUPTED. THE OPERATOR IS INSTRUCTED TO CONTACT THE SERVICE DEPARTMENT AND CHECK S135 AND PM134 FOR POSSIBLE MALFUNCTION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DIRTY WASH PROBE SENSOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED ERROR "4337 WASH-Y POSITIONING OVERRUN" WITH THEIR AIA-900 ANALYZER. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT BY REBOOTING THREE TIMES; HOWEVER, THE ISSUE PERSISTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR PROLACTIN (PRL), BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), FOLLICLE-STIMULATING HORMONE (FSH), ESTRADIOL (E2), PROGESTERONE II (PROG II), AND LUTEINIZING HORMONE (LH II). 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
    687473 AIA-900 AIA-900 KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1