BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4004870 · Received July 23, 2014

    Report

    Report Number
    2249723-2014-00941
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE OBSERVED THAT THERE WAS A LARGE AMOUNT OF WATER IN THE IABP BETWEEN THE CART AND THE BATTERY CASING, ON THE FRONT END PRINTED CIRCUIT BOARD, MOTOR CONTROL PRINTED CIRCUIT BOARD, ECG AND BP CABLE CONNECTORS, RS232 CABLE AND PUMP COMPRESSOR CABLE. THE MAIN BOARD TO MOTOR CONTROL BOARD CABLE (PART NUMBER 0012-00-075902), ECG INPUT TO FRONT END CABLE (PART NUMBER 0012-00-0977), PCB FRONT END MODULE (PART NUMBER 0671-00-0004) WERE REPLACED. THE COMPANY REPRESENTATIVE CHECKED PNEUMATIC PERFORMANCE SERVICE DIAGNOSTICS, AND PERFORMED FUNCTIONAL AND ELECTRICAL SAFETY TESTS. THE UNIT MET THE FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THEY WERE SETTING UP THE UNIT FOR USE WITH A PT, AN ELECTRICAL TEST FAILURE CODE 117 (FRONT END A/D REFERENCE FAILURE AT POWER UP) WAS OBSERVED ON DISPLAY. THE UNIT WAS REPLACED WITH ANOTHER UNIT AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429973 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1