BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3950719 · Received June 6, 2014

    Report

    Report Number
    2249723-2014-00870
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    December 3, 2013
    Report Date
    December 3, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 COMP SVC REP REPLACED THE DRIVE MANIFOLD (PART NO: 0104-00-0018). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE DRIVE MANIFOLD WAS RETURNED TO THE MANUFACTURING FACILITY AT MAHWAH NJ. THE EVAL IS IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT THE IABP GENERATED AN "ELECTRICAL TEST FAILURE CODE 58" (POWER-UP VENT TEST FAILED) ALARM. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331791 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1