BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 21408238 · Received February 19, 2025

    Report

    Report Number
    2249723-2025-0000747
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 12, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN BLOCK E1 INITIAL REPORTER FULL NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) INSPECTED UNIT AND REPLACED PCB, VIDEO RECEIVER (0670-00-0736) AND CABLE, DISPLAY TO VIDEO RCVR BD. (0012-00-1429). THE MACHINE IS NOT YET FULLY REPAIRED. IN FUTURE IF WE RECEIVE ANY UPDATE REGARDING REPAIR WILL REOPEN AND UPDATE THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ROUTINE CHECK THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EXHIBITED SCREEN FLICKERING. NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59252 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown