BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 23901454 · Received December 27, 2025

    Report

    Report Number
    2249723-2025-0005310
    Event Type
    Malfunction
    Date Received
    December 27, 2025
    Date of Event
    December 3, 2025
    Report Date
    February 16, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CS100 UPGRADED TO CS300. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, G3, G6, H2, H11. CORRECTED FIELD: H11. A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE DISPLAY ASSEMBLY AND REPLACED THE VIDEO RECEIVER BOARD (D670-00-0736) & PCB, INVERTER, DC TO AC (D671-00-0230) TO IMPROVE THE SYMPTOMS. RETURN UNIT TO CUSTOMER FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0670-00-0736 PCB, COLOR VIDEO RECEIVER SERIAL NUMBER (B)(6). PART NUMBER 0671-00-0230 INVERTER BOARD DC TO AC SERIAL NUMBER (B)(6). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF - SCREEN IS SHOWING BARS. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-0736 PCB, COLOR VIDEO RECEIVER SERIAL NUMBER (B)(6) AND PART NUMBER 0671-00-0230 INVERTER BOARD DC TO AC SERIAL NUMBER (B)(6) INTO THE CS300 TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PARTS TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV. W. AFTER FORTY-FIVE MINUTES OF RUN-TIME THE FAT DEPT. COULD NOT REPLICATE THE COMPLAINT OF THE SCREEN SHOWING BARS. THE PARTS PASSED TESTING. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9, G3, G6, H2,H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS), H11 A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE DISPLAY ASSEMBLY AND REPLACED THE VIDEO RECEIVER BOARD (D670-00-0736) & PCB,INVERTER, DC TO AC (D671-00-0230) TO IMPROVE THE SYMPTOMS. RETURN UNIT TO CUSTOMER FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK CS300 HAD THE DISPLAY ISSUE. SCREEN IS SHOWING BARS ON IT NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564584 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown