BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 8786035 · Received July 12, 2019

    Report

    Report Number
    8031673-2019-00250
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 12, 2019
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: A FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. THE CUSTOMER HAD RUN QUALITY CONTROLS (QC) WITH NO ERRORS WHEN THE FSE ARRIVED AT THE SITE. THE FSE CONFIRMED THE REPORTED ERROR MESSAGE IN THE ERROR LOG BUT WAS NOT ABLE TO REPRODUCE IT. THE FSE INSPECTED THE HYBRID ARM AND FOUND NO ISSUES. DURING FURTHER EVALUATION, THE FSE FOUND THE MAIN INCUBATOR VERY DIRTY WITH BLACK DUST, WHICH PROBABLY PREVENTED IT FROM TURNING PROPERLY. THE FSE CLEANED AND LUBRICATED THE INCUBATOR AND ALL MECHANISMS IN THE SORTER AND INSTRUMENT. THE FSE PROCEEDED TO RUN A MACRO PROGRAM FOR CUP TRANSFER, WHICH PASSED WITHOUT ISSUES. THE FSE THEN RAN 15 TEST CUPS WITHOUT ANY ISSUES. THE AIA-2000 INSTRUMENT WAS VALIDATED BY RUNNING CUSTOMER-PREPARED QUALITY CONTROLS, WHICH RESULTS PASSED WITHIN PUBLISHED RANGES, PER THE PACKAGE INSERT. NO FURTHER ACTION WAS REQUIRED. LATER DURING THE DAY THE CUSTOMER CALLED TO REPORT THAT ERROR MESSAGE "4273 HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN" HAD RETURNED AFTER FSE VISIT. THE FOLLOWING DAY, THE FSE VISITED THE CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. DURING EVALUATION, THE FSE CONFIRMED THAT THE ERROR LOG SHOWED ERROR MESSAGES "4211 MAIN ARM Y-AXIS HOME DETECTION FAILURE" AND "4224 INTERFERENCE OF DISPENSING NOZZLE Z-AXIS OF MAIN ARM", WHICH WERE RELATED TO CAP DETECTION AND MAIN ARM MOVEMENT. THE FSE WAS UNABLE TO REPRODUCE THE ERROR MESSAGES BUT FOUND THE WIRING TO THE MAIN ARM CAP DETECTION NOT PROPERLY SECURE AND POSSIBLY ABLE TO SNAG DURING MOVEMENT. THE FSE SECURED ALL WIRING TO THE MAIN ARM, VERIFIED HYBRID ARM AND RAN A CUP TRANSFER MACRO, WHICH PASSED. NO ERRORS WERE GENERATED. THE AIA-2000 INSTRUMENT WAS VALIDATED BY RUNNING CUSTOMER-PREPARED QUALITY CONTROLS, WHICH RESULTS PASSED WITHIN PUBLISHED RANGES, PER THE PACKAGE INSERT. THE AIA-2000 INSTRUMENT WAS WORKING WITHIN MANUFACTURER'S SPECIFICATION. NO FURTHER ACTION WAS REQUIRED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR SERIAL NUMBER (B)(4) FROM 25-MAY-2018 THROUGH AWARE DATE 25-JUN-2019. THERE WERE NO OTHER SIMILAR EVENTS REPORTED DURING THE SEARCHED PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER A4. APPENDIX 4: ERROR MESSAGES, STATES THE FOLLOWING: [4273] HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN. CAUSE: THE HOME SENSOR ACTIVATED IMPROPERLY AFTER MOVEMENT OF THE HYBRID CUP TRANSFER Z-AXIS. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. [4211] MAIN ARM Y-AXIS HOME DETECTION FAILURE. CAUSE: THE HOME SENSOR FAILED TO ACTIVATE AFTER THE MAIN ARM Y-AXIS MOVED TOWARD THE HOME POSITION. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. [4224] INTERFERENCE OF DISPENSING NOZZLE Z-AXIS OF MAIN ARM. CAUSE: THERE IS A POSSIBILITY THAT THE DISPENSING NOZZLE WAS INTERFERED WITH AN OBSTACLE SUCH AS CAP OF PRIMARY TUBE. THE MEASUREMENT RESULT WILL BE FLAGGED WITH THE SS FLAG. OR A COMMAND OR ADJUSTMENT VALUE (P05, 191-210) WAS GIVEN FOR MOVEMENT BEYOND THE MAXIMUM MOVABLE DISTANCE OF THE MAIN ARM Z-AXIS IN THE MAINTENANCE OPERATION. SOLUTION: REMOVE AN OBSTACLE SUCH AS CAP OF PRIMARY TUBE, IF ANY. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE INCUBATOR BEING FULL OF DUST AND THE MAIN ARM CAP DETECTION NOT BEING PROPERLY SECURED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERROR MESSAGE "4273 HYBRID CUP TRANSFER Z-AXIS HOME OVERRUN" FREQUENTLY, PREVENTING THE AIA-2000 INSTRUMENT FROM BEING RUN. THE CUSTOMER REQUESTED SERVICE TO INVESTIGATE THE ISSUE. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF CARDIAC TROPONIN I (CTNL 2), BETA HUMAN CHORIONIC GONADOTROPIN (BHCG), AND PROLACTIN (PRL) PATIENT RESULTS. 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
    579932 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1