BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS30+0

    MDR report key: 4122493 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01388
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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 FRACTURE IAB FILL LUER FITTING. THE COMPANY REP REPLACED THE IABP LUER FITTING (PART # 0103-00-0398-01). THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT THE IABP FAILING SAFETY DISK LEAK TEST. THE IABP WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587489 CS30+0 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1