BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 20998939 · Received December 23, 2024

    Report

    Report Number
    2249723-2024-0005180
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Report Date
    April 23, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E2, E3, G1, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D1, D4 (CATALOG , VERSION OR MODEL , SERIAL), H3. D4 (UDI) IS UNKNOWN (INITIALLY IT WAS SUBMITTED AS (B)(4). A GETINGE FIELD SERVICE ENGINEER (FSE) SENT A QUOTATION TO THE CLIENT FOR AN ON-SITE REPAIR (REPLACEMENT OF THE REFERENCE 0012-00-0976) AND WAITING FOR A FEEDBACK FROM THE CLIENT. AFTER DOING 3 GFE WE HAVEN'T RECEIVED ANY INFORMATION. AS OF NOW, THE INVESTIGATION IS CLOSED, IF ANY NEW INFORMATION IS RECEIVED FUTURE RELATED TO PART REPLACEMENT WILL REOPEN THE COMPLAINT AND UPDATE IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORITC BALLOON PUMP (IABP) DEVICE NO LONGER RECOGNIZES ECG.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627920 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0446-61

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.