BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 1942143 · Received November 15, 2010

    Report

    Report Number
    2248721-2010-00166
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    KQG
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULT, CONCLUSION: MFR/EVAL/INVESTIGATION PENDING PRODUCT RETURN FROM USER FACILITY. (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS HEMOCHRON RESPONSE INSTRUMENT GAVE AN UNEXPECTED ACT OF 1200 AND THEN GAVE AN EXPECTED ACT RESULT OF 506. NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON RESPONSE COAGULATION SYSTEM HEMOCHRON RESPONSE COAGULATION ANALYZER KQG INTERNATIONAL TECHNIDYNE CORPORATION HRS.110

    Patients

    Seq Age Sex Outcome Treatment
    1