BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 23447749 · Received November 3, 2025

    Report

    Report Number
    2249723-2025-0004521
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 13, 2025
    Report Date
    February 20, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: G4. SYS 98 UPGRADED TO CS300. CATALOG #: 0998 00 3023 53, UDI #: (B)(4), 510K: K063525, CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V. REVERT THE CONTENTS OF SECTION D1 (BRAND NAME), D4 (CATALOGUE NO, UDI NO, 510K) TO BLANK FROM INITIAL MDR # (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: H6(MEDICAL DEVICE PROBLEM CODE). IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD SALINE DAMAGE ON THE PCBS, TRIGGERED A LOW ALARM, AND HAD A BROKEN SD CARD RETAINER CLIP. PATIENT INVOLVEMENT UNKNOWN AND NO ADVERSE EVENT REPORTED. CUSTOMER STATED UNIT MAY BE REPLACED. THEY WILL REACH OUT IF NEEDED. NO REPAIR INFORMATION AVAILABLE. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD SALINE DAMAGE ON THE PCBS, TRIGGERED A LOW ALARM, AND HAD A BROKEN SD CARD RETAINER CLIP. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710212 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown