BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 9699475 · Received February 12, 2020

    Report

    Report Number
    2249723-2020-00224
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 10, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE INTRA-AORTIC BALLOON PUMP (IABP). THE STM CHECKED THE POWER SUPPLY INTAKE, IT WAS CLEAN OF DEBRIS AND THE FAN WAS MOVING FREELY. THE STM REMOVED THE POWER SUPPLY, REMOVED THE COVER AND VACUUMED THE INTERIOR THEN REINSTALLED THE POWER SUPPLY. THE STM COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ERROR CODE 7, POWER SUPPLY FAN ISSUE. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED HOWEVER; NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166000 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1