BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4004886 · Received July 23, 2014

    Report

    Report Number
    2249723-2014-01043
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K062525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE FOUND THE GROMMET THAT SEPARATES THE PUMP COMPRESSOR CABLE FROM THE PUMP COMPRESSOR HOUSING HAD DRIED OUT, BECOMING BRITTLE, AND WAS IN SEVERAL PIECES - THIS ALLOWED THE YELLOW WIRE FROM THE CABLE ASSEMBLY TO WEAR AWAY THE INSULATION AS IT RUBBED AGAINST THE PUMP COMPRESSOR HOUSING. THE COMPANY REPRESENTATIVE REPLACED THE COMPRESSOR MOTOR ASSEMBLY (0102-00-0001). PARTS THAT WERE REPLACED - P/N'S 348-01-0012 GROMMET, 354-00-0046 GASKET RIGHT PANEL, 008-00-0331 TUBING ASSEMBLY FILTER, 343-00-0073 P-CLAMP W/MOUNTING, 103-00-0065 PNEU MUFFLER, 103-00-0370 PNEU FILTER ELEMENT AIR, 354-00-0042-01 GASKET FLTR 5/16 X 7/8, 354-00-0042-02 GASKET FLTR 1/2 X 3/16. IN AN UNRELATED REPAIR THE 5000 HOUR PM KIT WAS ALSO INSTALLED. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. NO PATIENT INJURY WAS REPORTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT THE IABP GENERATED AN INTERMITTENT ELECTRICAL CODE FAIL #51 (ADJUSTED MOTOR SPEED OUT OF SPECIFICATION). NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429798 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1