BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 17181210 · Received June 22, 2023

    Report

    Report Number
    2249723-2023-02880
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 12, 2023
    Report Date
    February 14, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. TO FIX THE ISSUE, THE FSE REPLACED 0406-00-0916, 0670-00-0736, 0012-00-1747, 0012-00-1422, 0160-00-0113 , AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS SCREEN ISSUES. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62623 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown