BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16264343 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00699
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    April 1, 2021
    Report Date
    January 11, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE RESOLVED THE ISSUE BY REPLACING THE REAR PANEL (0380-00-0435) AND ALL LABELS (0334-00-2602-01 & 0334-00-2603-01). THE FSE THEN PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PREVENTATIVE MAINTENANCE (PM) SERVICE REPAIR PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS FOUND WITH DAMAGE ON THE SIDE PANEL, REPORTEDLY DUE TO CUSTOMER NEGLIGENCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.