BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3980209 · Received July 2, 2014

    Report

    Report Number
    2249723-2014-01010
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE DID NOT FIND THE 'ELECTRICAL ERROR CODE' ON THE ALARM LOGS FOR THE EVENT TIME FRAME. HE EVALUATED THE IABP WITH A TRAINER UNIT AND A SENSATION PLUS IAB. HE COULD NOT RECREATE THE ELECTRICAL ERROR CODE. THE COMPANY REP ADVISED THE CUSTOMER TO CONTACT THE "IN HOUSE" BIOMED SERVICE DEPT THAT PROVIDES SUPPORT ON THE CS300S AT (B)(6). THE CUSTOMER IN-HOUSE CLINICAL ENGINEER DOES NOT HAVE A RECORD OF A PROBLEM WITH THIS IABP IN (B)(6) 2013 NOR A WORK ORDER REQUEST FOR THIS IABP FOR THE TIME PERIOD OF THE COMPLAINT. CLINICAL ENGINEERING REPORTED THAT THE (B)(4) REPRESENTATIVE HAS PERFORMED PM ON THIS IABP SINCE (B)(6) 2013 AND "IT PASSED." (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, THE PUMP WAS TURNED ON AND GAVE AN "ELECTRICAL TEST FAILURE CODE" ALARM. THE CUSTOMER REPLACED THE IABP AND INITIATED THERAPY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388826 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1