BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V

    MDR report key: 21398089 · Received February 18, 2025

    Report

    Report Number
    2249723-2025-0000726
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108759
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION. INITIAL REPORTER FULL NAME: MAQUET PORTUGAL LDA. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, G3, G6, H2, H3, H6 (COMPONENT CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, TYPE OF INVESTIGATION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND SEVERAL FAULTS WERE DETECTED. FSE REPLACED PRESSURE SENSORS X1 AND X2 FAULTY (0682-00-0076-01), DRIVE ASSEMBLY (0104-00-0018), FILL MANIFOLD (0104-00-0023). THE FOLLOWING WAS ALSO MISSING: SUPPORT (IV POLE) (0436-00-0199), POWER CABLE (0012-00-0886-02), BAG WITH DOPPLER (0154-01-0001). THE MATERIAL TO REPLACE AND REPLENISH WAS ORDERED. ON 5-02-2025 REPLACEMENT OF IDENTIFIED COMPONENTS AND CALIBRATION OF ALL EQUIPMENT. VERIFICATION, PREPARATION OF SERVICE PROTOCOL AND FUNCTIONAL TESTS. OPERATIONAL EQUIPMENT. UNIT RETURNED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD PRESSURE TRANSDUCER DRIVE MANIFOLD PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191099 CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-UC-3023-58 10607567108759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown