BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V

    MDR report key: 18034432 · Received October 30, 2023

    Report

    Report Number
    2249723-2023-04644
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 20, 2023
    Report Date
    July 1, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107509
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, E1(NAME),(IMPACT). CORRECTED DATA: E1 ( EMAIL).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID. SUSPECT DEVICE ORIGINALLY DISTRIBUTED AS A SYS98XT, UPGRADED TO CS300 USING CONVERSION KIT. NO UDI IS PROVIDED AS PRODUCT WAS DISCONTINUED PRIOR TO GUDID IMPLEMENTATION TIMELINE.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: D1, D4 (# UDI), G4 (510 K), H6 (MEDICAL DEVICE ¿ PROBLEM CODE). UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) STATES, SCREEN PROBLEM NOT OBSERVED, DONE DISASSEMBLY OF THE SCREEN CASINGS. DISASSEMBLY OF THE SCREEN CABLE PRESENT. INSTALLATION OF THE NEW CABLE (D012-00-1059). REASSEMBLY OF COVER OK. FUNCTIONAL TEST OK. ELECTRICAL TEST OK. EVERYTHING WORKS CORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING START UP, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A SCREEN PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942067 CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0446-64 10607567107509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown