BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 15708728 · Received November 1, 2022

    Report

    Report Number
    2249723-2022-02803
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 20, 2022
    Report Date
    June 26, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE DISPLAY TO VIDEO RECEIVER CABLE (0012-00-1429). THE IABP WAS RETURNED TO THE CUSTOMER IN GOOD, WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY IS FLICKERING. RECONNECTED ALL CABLES OF DISPLAY , IF PROBLEM PERSIST AGAIN THEN WILL CHANGE DISPLAY TO VIDEO RECEIVER CABLE FIRST FOR FURTHER TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY IS FLICKERING. RECONNECTED ALL CABLES OF DISPLAY , IF PROBLEM PERSIST AGAIN THEN WILL CHANGE DISPLAY TO VIDEO RECEIVER CABLE FIRST FOR FURTHER TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457958 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 Unknown