BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 22286327 · Received June 18, 2025

    Report

    Report Number
    2249723-2025-0002652
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 16, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, B5, G3, G6, H2, H11. UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED ONLY ROUTINE MAINTENANCE OF BATTERY. THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA. AS A RESULT, NO FOLLOW UP EMDR IS NECESSARY. PLEASE CANCEL MFG REPORT NUMBER 2249723-2025-0002652 IN YOUR DATABASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SHOWED BATTERY MAINTENANCE REQUIRED ALERT. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW IT WAS DETERMINED THAT THE REPORTED EVENT INVOLVED ONLY ROUTINE MAINTENANCEOF BATTERY. THERE WAS NO MALFUNCTION OF THE DEVICE AND THEREFORE THE EVENT DOES NOT MEET THE DEFINITION OF AN INCIDENT/SERIOUS INCIDENT, MAKING IT NON-REPORTABLE TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496500 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown