BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4122488 · Received September 22, 2014

    Report

    Report Number
    2249723-2014-01386
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    April 8, 2013
    Report Date
    April 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP TESTED UNIT AND OBSERVED IN THE FAULT LOG, "AUTOFILL FAILURE" CODE 90 (TRANSDUCER ATMOSPHERIC CALIBRATION FAILURE). ISSUE WITH K6 IN DRIVE ASSEMBLY. THE COMPANY REP REPLACED THE DRIVE ASSEMBLY (0104-00-0018). 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 A PT, THE UNIT DISPLAYED A "LEAK ALARM" AND COULD NOT AUTOFILL. 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
    587620 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300

    Patients

    Seq Age Sex Outcome Treatment
    1