BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 8003981 · Received October 25, 2018

    Report

    Report Number
    8031673-2018-00704
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    August 17, 2017
    Report Date
    October 25, 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. THIS RECORD IS BEING SUBMITTED LATE AS PART OF A RETROSPECTIVE REVIEW PER (B)(4), COMPLAINT RETROSPECTIVE REVIEW AND REMEDIATION PROTOCOL. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, INSPECTED THE INSTRUMENT AND CONFIRMED THE FAILURES. FSE OBSERVED A LOOSE WASH PROBE COLLAR THAT WAS CAUSING THE PROBE TO HIT THE WASH PORT SIDE. THE WHITE COLLAR NUT TO THE BASE WAS TIGHTEN TO KEEP THE PROBE FROM WOBBLING, THE WASH WELL WAS ADJUSTED, THE WASHER GEAR LUBRICATED AND THE CAROUSEL CLEANED. FSE THEN RAN QUALITY CONTROLS AND THE RESULTS WERE WITHIN SPECIFICATION RANGE. THE INSTRUMENT WAS PERFORMING AS INTENDED. THE PROBABLE CAUSE OF THIS EVENT WAS A LOOSE WASH PROBE NUT. A 13-MONTH COMPLAINT AND SERVICE HISTORY REVIEW FOR AIA-360 ANALYZER SERIAL NUMBER (B)(4) FROM 17-JUL-2016 TO 17-AUG-2017 WAS PERFORMED FOR SIMILAR COMPLAINTS. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCH PERIOD. THE AIA-360 SERVICE MANUAL REVISION 1, UNDER CHAPTER 8 - TROUBLESHOOTING - ERROR MESSAGES WAS REVIEWED AND STATES THE FOLLOWING: 4039 WASH PROBE HOME NOT FOUND - THE AIA-360 SERVICE MANUAL UNDER CHAPTER 8- TROUBLESHOOTING INDICATES THAT THE 4039 WASH PROBE HOME NOT FOUND ERROR MESSAGE IS GENERATED WHEN THE B/F PROBE MOTOR HOME SENSOR FAILS TO ACTIVATE WHEN IN THE HOME POSITION. THE OPERATOR IS INSTRUCTED TO INSPECT MOTOR PN401 AND SENSOR S401.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING A RANDOM ERROR 4039 (WASH PROBE HOME NOT FOUND). CUSTOMER NOTED HEARING "GRINDING "SOUND IN THE SAME TIME. THE CUSTOMER TRIED TROUBLESHOOTING BY RE-BOOTING WHICH DID NOT RESOLVE THE ISSUE. THE CUSTOMER REQUESTED SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING LHII, PROG, E2, FSH AND 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
    845350 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1