BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-2000

    MDR report key: 9044053 · Received September 13, 2019

    Report

    Report Number
    8031673-2019-00355
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 23, 2019
    Report Date
    March 18, 2020
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPRESSION COIL SPRING FOR SORTER (PART # 022349), SORTER TIP NOZZLE (PART # 022304), AND TIP NOZZLE SET SCREW (2X) (PART # 250067) WERE RETURNED TO TOSOH INSTRUMENT SERVICE CENTER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT CONFIRM THE REPORTED ISSUE WAS DUE TO FAILURE OF THE RETURNED PARTS AS THE ERROR COULD NOT BE DUPLICATED. THE PROBABLE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL HAS BEEN COMPLETED TO CORRECT/CHANGE THE EVENT DATE FROM (B)(6) 2019 TO (B)(6) 2019 AS THE EVENT DETAILS INDICATE THAT THE COMPLAINT STARTED THE DAY BEFORE THE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS AT CUSTOMER SITE TO ADDRESS THE REPORTED EVENT. THE FSE WAS ABLE TO CONFIRM AND REPRODUCE THE ISSUE BY RUNNING CORNER TIPS MACRO. THE ISSUE WAS RESOLVED BY REPLACING THE COMPRESSION COIL SPRING, TIP NOZZLE, AND PREFORMING TIP ALIGNMENT. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE AIA-2000 INSTRUMENT IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 24JUL2018 THROUGH AWARE DATE (B)(6) 2019. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE REVIEW PERIOD. THE AIA-2000 OPERATOR'S MANUAL UNDER APPENDIX 4: ERROR MESSAGE STATES THE FOLLOWING: 2060 - TIP ATTACHMENT FAILURE BY MAIN ARM, CAUSE: NO TIP WAS DETECTED BY TIP ATTACHMENT CHECK. IF RETRY FAILS, THE MEASUREMENT RESULT WILL BE FLAGGED (MF FLAG). SOLUTION: CONTACT TOSOH SERVICE CENTER OR LOCAL REPRESENTATIVES. THE PROBABLE CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN DETERMINED; INVESTIGATION IS CURRENTLY IN-PROCESS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING ERROR MESSAGE 2060 TIP ATTACHMENT FAILURE BY MAIN ARM ON THE AIA-2000 INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING OF PROGESTERONE (PROG II), LUTEINIZING HORMONE (LH II) 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
    818650 AIA-2000 AIA-2000 KHO TOSOH CORPORATION AIA-2000

    Patients

    Seq Age Sex Outcome Treatment
    1