BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR. SIGNATURE PLUS SYSTEM

    MDR report key: 2449680 · Received January 31, 2012

    Report

    Report Number
    2248721-2012-00005
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 3, 2012
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER PROVIDED CUVETTE LOT # H1JLR136 AND G1JLR106. METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION PERFORMED CUVETTE DEVICE HISTORY RECORDS REVIEWED. NO RELATED NCMRS, COMPLAINT TRENDS OR CAPA IDENTIFIED. RESULT: NO RESULTS TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. DEVICE NOT RETURNED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS ACT-LR RESULT NOT AS EXPECTED WITH HEMOCHRON JR. SIGNATURE PLUS SYSTEM. DURING A CARDIAC ABLATION PROCEDURE, INSTRUMENT GENERATED ACT-LR RESULT OF >400 SECONDS. HEPARIN DOSE WAS ADJUSTED AND RETESTED 15 MINUTES LATER GENERATING AN ACT-LR RESULT OF 205 SECONDS. NO ADVERSE EVENT(S) REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCHRON JR. SIGNATURE PLUS SYSTEM JPA INTERNATIONAL TECHNIDYNE CORP. PSIG

    Patients

    Seq Age Sex Outcome Treatment
    1