BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4212947 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01113
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    December 5, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE MANIFOLD DRIVE ASSEMBLY ((B)(4)). THE COMPANY REP PERFORMED FULL FUNCTIONAL AND SAFETY TESTS. (B)(4).

    Description of Event or Problem · 1

    THE COMPANY REP REPORTED THAT THE IABP AT THE CUSTOMER SITE GENERATED AN ELECTRICAL TEST FAILURE CODE #58 (POWER-UP VENT TEST FAILED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455473 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1