BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122482 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01381
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED TWO FAILURES, SAFETY DISK NOT FULLY LOCKED IN POSITION AND THE PUMP WOULD NOT FILL. THE COMPANY REP SECURED THE SAFETY DISK IN LOCK POSITION AND IT PASSED ALL LEAK TESTS. THE COMPANY REP REPLACED THE FILL MANIFOLD (PART # 0104-00-0023). 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 THE PT, THE IABP COULD NOT AUTO FILL THE IAB. 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
    587619 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1