BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 21617041 · Received March 17, 2025

    Report

    Report Number
    2249723-2025-0001232
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 27, 2025
    Report Date
    May 6, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, EVENT SITE NAME -(B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) OBSERVED AND FOUND THE CABLE TO BE EXPOSED. QUOTED THE CABLE. THE CABLE (D012-00-0886-02) WAS REPLACED AND UNIT TESTED OK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-USE INSPECTION, THE CS300 INTRA-AORTIC BALLOON PUMP'S (IABP) CHARGING CABLE WIRES EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17322 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown