BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA 2000

    MDR report key: 7322716 · Received March 7, 2018

    Report

    Report Number
    8031673-2018-00173
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 7, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 (B)(6) 2018, FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER'S SITE, FSE FOUND BF PULSE MOTOR CABLE DEFECTIVE. FSE REPLACED THE CABLE, CLEANED AND LUBRICATED THE MAIN ARM AND HYBRID ARM NOZZLE ASSEMBLIES. FSE ALSO CLEANED THE TIP DISCARD SHOOT FOR THE MAIN ARM. FSE PERFORMED SEVERAL WASH PRIMES SUCCESSFULLY WITHOUT ERRORS. CUSTOMER COMPLETED QUALITY CONTROL RUN, ALL WITHIN EXPECTED RANGE. THE AIA 2000 INSTRUMENT IS FUNCTIONING WITHOUT ERRORS AFTER COMPLETING THE REPAIR. A 13 MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM (B)(6) 2017 THROUGH (B)(6) 2018. THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED DURING THE SEARCHED PERIOD. THE AIA 2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGES, STATES THE FOLLOWING: (4451) B/F PROBE 2 HOME DETECTION FAILURE IS GENERATED WHEN THE HOME SENSOR FAILS TO ACTIVATE AFTER THE B/F PROBE 2 MOVED TOWARD THE HOME POSITION. THE MEASURING OPERATION IS SUSPENDED. SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO BROKEN WIRE OR WIRES IN B/F 2 PULSE MOTOR CABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, CUSTOMER REPORTED GETTING ERROR CODE 4451 "BF PROBE 2 HOME DETECTION FAILURE" UPON STARTUP ON AIA 2000 INSTRUMENT. CUSTOMER TRIED REBOOTING THE SYSTEM BUT ERROR PERSISTED. CUSTOMER STATES SHE IS UNABLE TO OPEN THE BF PROBE DOOR ON THE INSTRUMENT TO ACCESS THE PROBE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY IN REPORTING OF PATIENT RESULTS FOR INTACT PARATHYROID HORMONE (IPTH). 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
    163559 AIA 2000 AIA 2000 KHO TOSOH CORPORATION AIA 2000

    Patients

    Seq Age Sex Outcome Treatment
    1