BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE PLUS MICROCOAGULATION SYS

    MDR report key: 1922093 · Received November 16, 2010

    Report

    Report Number
    2248721-2010-00170
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY RECORD, NCMR, CAPA AND COMPLAINT HISTORY EVALUATED. RESULT: RECORD EVAL COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    HEALTHCARE PROVIDER REPORTS: SIGNATURE PLUS ACT RESULTS LOWER THAN EXPECTED. SIGNATURE PLUS GAVE A RESULT OF 173 SECONDS AND ON REPEAT 300 SECONDS. TARGET TIME FOR SHEATH PULL 170 SECONDS." NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON SIGNATURE PLUS MICROCOAGULATION SYS HEMOCHRON SIGNATURE PLUS MICROCOAG. SYS JPA INTERNATIONAL TECHNIDYNE CORPORATION HE. JR. SIG. PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1