BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20588055 · Received November 1, 2024

    Report

    Report Number
    2249723-2024-0004510
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 14, 2024
    Report Date
    November 12, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6( HEALTH EFFECT - CLINICAL, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT, INVESTIGATION CONCLUSIONS),H11. THE FSE THAT ENCOUNTERED THE ISSUE STATED THAT THE INSULATION OF THE MAINS POWER CORD WAS DAMAGED AND THAT THE INTERNAL LEADS WERE EXPOSED. THERE WERE NO BARE WIRES, BUT THE CORD WAS NO LONGER WATER TIGHT. THE FSE REPLACED THE AC LINE CORD (0012-00-0886-01). THE FSE PERFORMED A FULL PM WITH CALIBRATION, SAFETY, AND FUNCTIONAL CHECKS TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND RELEASED FOR CLINICAL SERVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) POWER CORD IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632554 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