BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V

    MDR report key: 20761211 · Received November 22, 2024

    Report

    Report Number
    2249723-2024-0004787
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 5, 2024
    Report Date
    May 7, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108322
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT, EVENT SITE NAME - (B)(6) HOSPITAL. UPDATED FIELDS -B3, B4, D8, D9, E1, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND NO RECURRENCE WAS OBSERVED. FSE REPLACED THE ECG INPUT PART (0012-00-0976), WHICH IS THOUGHT TO BE THE CAUSE. EVEN AFTER THE REPLACEMENT, THERE WERE NO SYMPTOMS OF ECG INPUT BEING CUT OUT. THE EQUIPMENT IS IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) DIRECT SIGNAL IS NOT INPUT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2606258 CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-65 10607567108322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown