BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-360

    MDR report key: 7295174 · Received February 25, 2018

    Report

    Report Number
    8031673-2018-01223
    Event Type
    Malfunction
    Date Received
    February 25, 2018
    Date of Event
    September 16, 2015
    Report Date
    February 24, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE (B)(6) 2015 FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE FSE FOUND BROKEN WIRES ON CONNECTOR PM202 FOR THE Z-AXIS MOTOR WHICH WAS REPLACED. THE CUSTOMER RAN QUALITY CONTROL WITHOUT ANY ERRORS. INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELEASED. A 13 MONTH COMPLAINT/ SERVICE HISTORY REVIEW FOR SERIAL NUMBER (B)(4) WAS PERFORMED AND FOUND NO OTHER COMPLAINTS WITH SIMILAR EVENTS. THE MOST PROBABLE CAUSE FOR THIS EVENT IS BROKEN WIRE CABLE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA(B)(4).

    Description of Event or Problem · 0

    ON THE (B)(6) 2015 THE CUSTOMER REPORTED ERROR 4019 SPEC Z AXIS HOME NOT FOUND. THE CUSTOMER CHECKED THE SAMPLE PROBE AND STATES THAT IT IS STRAIGHT. CUSTOMER IS HEARING CLICKING NOISE COMING FROM THE INSTRUMENT, THEY REMOVED THE SKIN BUT NO OBSTRUCTION IS EVIDENT. CUSTOMER REQUESTED SERVICE IN ORDER TO ADDRESS THE REPORTED ISSUE WHICH RESULTED IN DELAY REPORTING OF RESULTS FOR CKMB AND CTNI 2. 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
    138448 AIA-360 AIA-360 KHO TOSOH CORPORATION AIA-360

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability