BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 22492947 · Received July 14, 2025

    Report

    Report Number
    2249723-2025-0003004
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 28, 2025
    Report Date
    September 26, 2025
    Manufacturer
    DATASCOPE CORP.
    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

    DUE TO CHARACTER LIMITATIONS IN E1 EVENT SITE NAME- (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G1, G3, G6, H2, H6 (MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED AND RESET ALL CONNECTION OF DISPLAY BUT DISPLAY NOT WORKING SO REPLACED DISPLAY CONTROLLER BOARD (0670-00-0640), VIDEO RECEIVER BOARD (0670-00-0736) AND CABLE (0012-00-1059). HOWEVER DISTRIBUTOR HAS OBSERVED BATTERY BACKUP ISSUE AND ALSO RECOMMENDED TO REPLACE BATTERY MODULE AND SAFETY DISK AS EXPIRED FOR WHICH QUOTE WAS SUBMITTED BUT THERE WAS NO RESPONSE SO FAR FROM CUSTOMER SIDE. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS NOT FUNCTIONING. NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118920 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 N/A.