BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3905478 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00805
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 10, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE EVALUATED THE UNIT AND COULD NOT FIND ANY ERROR DISPLAYED OR ANY ERROR DOCUMENTED IN THE FAULTS LOG. PROCEEDED TO REPLACE THE FIBER OPTIC PRINTED CIRCUIT BOARD. THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE OPTIC PRINTED CIRCUIT BOARD IS BEING REQUESTED TO BE SENT TO THE MANUFACTURING FACILITY AT (B)(4) FOR EVALUATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE WITH A PATIENT, THE IABP DISPLAYED A FIBER OPTIC ERROR MESSAGE. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314992 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1