BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3905524 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00784
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    October 30, 2013
    Report Date
    October 30, 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 UNIT WAS RETURNED TO THE COMPANY OFFICE IN (B)(4) FOR SERVICE. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE UNIT AND CONFIRMED THE EVENT. IT WAS NOTED THAT THE MAIN BOARD WAS CAUSING THE FAILURE AND REPLACED THE MAIN BOARD (PART # 670-00-0788). THE COMPANY SERVICE REPRESENTATIVE PERFORMED THE FUNCTIONAL AND SAFETY CHECKS MEETING THE FACTORY SPECIFICATIONS. THE UNIT WAS RETURNED TO THE CUSTOMER. THE MAIN BOARD IS BEING RETURNED 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 DURING A PREVENTIVE MAINTENANCE ON THE IABP, THEY OBSERVED THAT THE IABP FAILED TO POWER UP. THE CUSTOMER SWITCHED THE POWER BUTTON ON OR OFF SEVERAL TIMES BUT THE IABP DID NOT POWER UP. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314970 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1