BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODYNAMIC MONITORING

    MDR report key: 4898968 · Received July 1, 2015

    Report

    Report Number
    MW5043698
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 23, 2015
    Report Date
    July 1, 2015
    Manufacturer
    CAMTRONICS/ MERGE HEALTHCARE
    Product Code
    ONA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EMERGENT HEART CATH PROCEDURE CAMTRONICA HEMODYNAMIC MONITORING SYSTEM WENT DOWN. OPERATOR DESCRIBED AS THE DATA DISPLAY FREEZING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426468 HEMODYNAMIC MONITORING HEMODYNAMIC MONITORING ONA CAMTRONICS/ MERGE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR