BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 23319863 · Received October 16, 2025

    Report

    Report Number
    2249723-2025-0004346
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 29, 2025
    Report Date
    January 5, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DUE TO CHARACTERIZATION LIMIT E1 (EVENT SITE NAME: (B)(6)). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11 (COMPONENT CODES,INVESTIGATION FINDINGS) A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT AND WAS ABLE TO CONFIRM THE REPORTED FAILURE. THE FSE FIXED IT BY CLEANING THE SCREEN RIBBON CABLE. FSE BROUGHT NEW SPARE PARTS TO REPLACE FOR THE CUSTOMER - CABLE, DISPLAY TO VIDEO RCVR BD (D012-00-1429). AFTER REPLACING THE SPARE PARTS, TESTED THE SCREEN OPERATION AND FOUND THAT IT COULD WORK NORMALLY. THE SYMPTOMS RETURNED TO NORMAL. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO NORMAL USE.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, E1 EVENT SITE MAIL, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT AND WAS ABLE TO CONFIRM THE REPORTED FAILURE. THE FSE FIXED IT BY CLEANING THE SCREEN RIBBON CABLE. THE SYMPTOMS RETURNED TO NORMAL. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO NORMAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN IS BLINKING, GREEN LINES ON THE SCREEN. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541396 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-55 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown