BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON RESPONSE COAGULATION SYSTEM

    MDR report key: 2093428 · Received April 12, 2011

    Report

    Report Number
    2248721-2011-00045
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K983475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEWED FOR NCMR AND CAPA. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RECORD EVAL COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. DEVICE PERFORMED ACCORDING TO SPECS. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. DEVICE OPERATED ACCORDING TO SPECS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    IN-COUNTRY REP FORWARDED A REPORT OF NO CLOT DETECTED ON HEMOCHRON RESPONSE INSTRUMENT. THE CUSTOMER OBSERVED NO CLOT DETECTED ERRORS ON HEMOCHRON RESPONSE COAGULATION SYSTEM. THIS EVENT OCCURRED OUTSIDE THE U.S. NO ADVERSE EVENT(S) REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1