BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 22887609 · Received August 25, 2025

    Report

    Report Number
    2249723-2025-0003592
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 7, 2025
    Report Date
    January 30, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE POWER SUPPLY (0014-00-0033-05), 5000H MAINTENANCE KIT (0040-00-0147) AND THE BATTERY (0997-00-0985-01) AND SAFETY DISK ASSEMBLY (0997-00-0985-01). PERFORMANCE CHECKS WERE MADE AND THE DEVICE WAS RETURNED TO THE USER IN WORKING CONDITION.

    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. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE POWER SUPPLY (0014-00-0033-05), 5000H MAINTENANCE KIT (0040-00-0147) AND THE BATTERY (0997-00-0985-01) AND SAFETY DISK ASSEMBLY (0997-00-0985-01). THE 0040-00-0147 (5000H MAINTENANCE KIT), 0146-00-0039 (BATTERY), AND 0997-00-0985-01 (SAFETY DISK) WERE ALL EXPIRED PREVIOUS TO THE REPLACEMENT. PERFORMANCE CHECKS WERE MADE AND THE DEVICE WAS RETURNED TO THE USER IN WORKING CONDITION.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTED DATA: H6 (INVESTIGATION FINDINGS , COMPONENT CODES).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CHECK BY CUSTOMER, CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A DEFECTIVE PART OF POWER SUPPLY. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499251 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