BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 22420316 · Received July 7, 2025

    Report

    Report Number
    2249723-2025-0002910
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 21, 2025
    Report Date
    July 23, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108575
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN THE E1 SECTION, THE FULL EVENT SITE NAME IS (B)(6). DUE TO CHARACTER LIMIT IN THE E1 SECTION, THE FULL EVENT SITE ADDRESS IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D9. UPDATED FIELDS: B4, G3, G6, H2, H11.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: D10, H11. THIS REPORT IS BEING SUBMITTED AS IN THE PREVIOUS MDR REPORT NUMBER - 2249723-2025-0002910, THE FIELD D9 WAS MENTIONED INSTEAD OF D10 IN THE H11. UPDATED FIELDS: B4, G3, G6, H2.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E1- INITIAL REPORTER NAME, G1-CONTACT PERSON AT MFG SITE, G3, G6, H2, H3, H6- TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODE AND H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE CAUSE OF THE EQUIPMENT FAILURE WAS DETECTED. THE MANIFOLD DRIVE, SAFETY DISK ASSY , KIT 5000 HR PREVENT MAINTENANCE WERE REPLACED. THE SAFETY DISK AND MAINTENANCE KIT WERE REPLACED DUE TO EXPIRY, THE EQUIPMENT PASSED ALL PERFORMANCE AND SAFETY INDEX TESTS SPECIFIED BY THE FACTORY AND CAN BE USED IN CLINICAL.

    Description of Event or Problem · 0

    IT WAS REEPORTED BY CUSTOMER THAT DURING USE, THAT THE CS300 INTRA AORTIC BALLOON PUMP HAD DISPLAYED ALRM BALLOON FAILURE TO INFLATE AND REPLACED IT WITH ANOTHER DEVICE. THERE WAS NO INJURY.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995 CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-45 10607567108575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ANOTHER IABP