BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4030624 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01000
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    August 7, 2011
    Report Date
    August 7, 2011
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DOES NOT USE (B)(4) FOR THE IABPS. THE COMPANY REP REPORTED THAT THE IABP UNIT IS FUNCTIONAL. SINCE THE EVALUATION WAS NOT PERFORMED BY (B)(4), NEITHER THE SERIAL NUMBER NOR THE RESOLUTION OF THE EVENT CAN BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT HAD A 40CC FIBEROPTIC IAB CATHETER ON A CS300 WITH AN AUTOFILL FAILURE ALARM. THE SURGEON REMOVED THE IAB BEFORE THE ACCOUNT MGR COULD TROUBLESHOOT THE ALARM. THERE WAS NOT ANOTHER FIBER OPTIC CATHETER AVAILABLE SO THEY REPLACED A TRADITIONAL CATHETER. THEY WERE SUCCESSFUL ATTACHING AND PUMPING ON A NEW CONSOLE. THE ACCOUNT MGR REQUESTED THAT THE OTHER PUMP BE FLAGGED AND CHECKED BY THE BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442907 CS300 UBTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300

    Patients

    Seq Age Sex Outcome Treatment
    1