BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20832320 · Received December 3, 2024

    Report

    Report Number
    2249723-2024-0004900
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 12, 2024
    Report Date
    April 28, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: G4 (PMA / 510(K)).UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11 FSE REPLACED DRIVE MANIFOLD (D104-00-00180) AND COMPLETED PM INCLUDING ALL FUNCTIONAL AND SAFETY TESTS AS PER MANUFACTURER SPECIFICATIONS. PLEASE SEE SERVICE ORDER (B)(4) FOR PM DETAILS. RELEASED UNIT TO CUSTOMER.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), H11. FSE REPLACED DRIVE MANIFOLD (D104-00-00180) AND COMPLETED PM INCLUDING ALL FUNCTIONAL AND SAFETY TESTS AS PER MANUFACTURER SPECIFICATIONS. PLEASE SEE SERVICE ORDER #45002046 FOR PM DETAILS. RELEASED UNIT TO CUSTOMER.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) FAILS K6,K7,K8 LEAKS TEST. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543151 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