BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP

    MDR report key: 14874913 · Received June 30, 2022

    Report

    Report Number
    2249723-2022-01535
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Report Date
    March 13, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    AT THIS TIME CUSTOMER HAS NOT REQUESTED GETINGE FOR EVALUATION. CUSTOMER BIOMED ENGINEER RESOLVED THE ISSUE BY REPLACING THE COILED VIDEO CABLE (PN: 0012-00-1422). THE EQUIPMENT WAS CLEARED FOR CUSTOMER USE. THE FINAL INVESTIGATION HAS BEEN COMPLETED BY FAILURE ANALYSIS AND TESTING DEPARTMENT. RETAINING THE COILED VIDEO CABLE IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. ADDITIONAL INFORMATION REQUESTED FROM SUPPORT IN REGARD TO THE REPAIR AND STATUS OF THE IABP WERE PERFORMED WITH NO RESPONSE. THEREFORE, WE ARE CLOSING THIS RECORD WITH NO FURTHER ACTION. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE REOPENED AND ADDRESSED ACCORDINGLY. BIOMED DONE THE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSTALLATION, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS FLICKERING. THE COILED CABLE FAILED UPON INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832431 CS300 INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown