BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3980268 · Received July 2, 2014

    Report

    Report Number
    2249723-2014-00738
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THE TRIGGERING ISSUES IN THE FAULT LOG BUT WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. DURING TESTING THE COMPANY REPRESENTATIVE OBSERVED ARTIFACT ON THE LEFT AND RIGHT SIDE OF THE SCREEN. THE COMPANY REPRESENTATIVE REPLACED THE COILED CABLE (PART NUMBER: 0012-00-1422) TO CORRECT THE DISPLAY. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP WAS HAVING ECG TRIGGER ISSUES AND PUMPING DIFFICULTIES. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387036 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1