BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 9860348 · Received March 20, 2020

    Report

    Report Number
    2249723-2020-00457
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    February 27, 2020
    Report Date
    June 3, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION, THE SOLENOID DRIVER BOARD THAT FAILED IS NO LONGER NEEDED TO BE RETURNED FOR FAILURE ANALYSIS. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SERVICE/ REPAIR OF A CS300 INTRA-AORTIC BALLOON PUMP (IABP) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THAT A NEW SOLENOID DRIVER BOARD FAILED; THE VOLTAGES CANNOT BE ADJUSTED WITHIN THE NECESSARY RANGE FOR BLOODBACK CALIBRATION. THIS IS AN OUT-OF-BOX (OOB) FAILURE OF THE BOARD. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SERVICE/ REPAIR OF A CS300 INTRA-AORTIC BALLOON PUMP (IABP) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THAT A NEW SOLENOID DRIVER BOARD FAILED; THE VOLTAGES CANNOT BE ADJUSTED WITHIN THE NECESSARY RANGE FOR BLOODBACK CALIBRATION. THIS IS AN OUT-OF-BOX (OOB) FAILURE OF THE BOARD. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. THE GETINGE SERVICE TERRITORY MANAGER (STM) WHO ENCOUNTERED THE ISSUE REPLACED THE SOLENOID DRIVER BOARD WITH ANOTHER WORKING ONE AND THEN COMPLETED A FULL PM. THE STM THEN PERFORMED ALL FUNCTIONAL AND SAFETY TESTS WHICH PASSED TO MEET FACTORY SPECIFICATIONS, AND THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THE FAULTY BOARD THAT FAILED OOB WILL BE RETURNED TO FACTORY FOR FAILURE ANALYSIS, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON ITS EVALUATION. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE/ REPAIR OF A CS300 INTRA-AORTIC BALLOON PUMP (IABP) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THAT A NEW SOLENOID DRIVER BOARD FAILED; THE VOLTAGES CANNOT BE ADJUSTED WITHIN THE NECESSARY RANGE FOR BLOODBACK CALIBRATION. THIS IS AN OUT-OF-BOX (OOB) FAILURE OF THE BOARD. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323056 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1