BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSD300 INTRA-AORTIC PUMP

    MDR report key: 3905495 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00776
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    September 26, 2013
    Report Date
    September 26, 2013
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 REPLACED THE DRIVE MANIFOLD ASSEMBLY (PART #0104-00-0018). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RELEASED TO THE CUSTOMER. THE DRIVE MANIFOLD ASSEMBLY REPLACED WAS RETURNED TO THE MANUFACTURING FACILITY AT (B)(4) AND IS UNDER EVALUATION ANALYSIS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, AN "AUTOFILL FAILURE" AND MAINTENANCE REQUIRED CODE #2 (DRIVE TRANSDUCER OFFSET FAILURE) ALARM WAS GENERATED. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315040 CSD300 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300

    Patients

    Seq Age Sex Outcome Treatment
    1