BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 13459150 · Received February 4, 2022

    Report

    Report Number
    2249723-2022-00229
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 5, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE (1003233): A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP AND WAS ABLE TO CONFIRM THE REPORTED ELECTRICAL TEST FAILURE 58. THE FSE REPLACED THE SOLENOID DRIVER BOARD AS PART OF A FIELD ACTION, AND PERFORMED A FULL PREVENTATIVE MAINTENANCE (PM) CHECK, UNIT HAS PASSED ALL TEST AND CALIBRATIONS AND IS NOW READY FOR CLINICAL USE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    TYPE OF INVESTIGATION NOT YET DETERMINED: ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE REPAIR AND STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THIS INFORMATION IS PROVIDED TO US.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS ALARMING FOR ELECTRICAL TEST FAILURE 58. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED OR IF A PATIENT WAS INVOLVED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS ALARMING FOR ELECTRICAL TEST FAILURE 58. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE EVENT OCCURRED. NO PATIENT INVOLVED. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126607 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown