BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V

    MDR report key: 19115245 · Received April 16, 2024

    Report

    Report Number
    2249723-2024-01556
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    April 2, 2024
    Report Date
    January 29, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107684
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G3, G6, H2, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS),H10. IT WAS REPORTED THAT DURING USE THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF NO ARTERIAL PRESSURE WAVEFORM WAS DISPLAYED. A GETINGE FIELD SERVICE ENGINEER TESTED BUT NO REPRODUCIBILITY. FSE HAVE ALREADY EXPLAINED TO THE HOSPITAL THAT IT IS NOT REPRODUCIBLE. THERE WAS PATIENT INVOLVEMENT. NO HEALTH DAMAGE REPORTED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) THERE WAS NO ARTERIAL WAVEFORM ON DISPLAY. OPERATED WITH ECG TRIGGER AND TRANSPORTED TO MIE UNIVERSITY HOSPITAL. TRANSFERRED TO CARDIOSAVE AT MIE UNIVERSITY HOSPITAL. THE CARDIOSAVE DISPLAYED ARTERIAL PRESSURE WAVEFORM AND FUNCTIONED NORMALLY. THERE WAS NO HEALTH HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672431 CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-65 10607567107684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRANSRAY CATHETER.