BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 16530660 · Received March 13, 2023

    Report

    Report Number
    2249723-2023-01469
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    March 3, 2023
    Report Date
    February 9, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE POSTAL CODE: (B)(6). ADDITIONAL CONTACT INFORMATION: (B)(6). THE GETINGE FIELD SERVICE ENGINEER (FSE) ENCOUNTERED THE REPORTED ISSUE DURING THE PREVENTATIVE MAINTENANCE (PM). FSE REPLACED THE DRIVE MANIFOLD AND SAFETY DISC TO FIX THE ISSUE AND PERFORMED A FULL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE PM WAS COMPLETED AND THE IABP WAS THEN RELEASED AND CLEARED FOR CLINICAL SERVICE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS LEAKS IN VALVE PACKAGE K6,K7,K8. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576721 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown