BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16258300 · Received January 27, 2023

    Report

    Report Number
    2249723-2023-00643
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 10, 2022
    Report Date
    March 16, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. IN ORDER TO FIX THE ISSUE, THE FSE REPLACED CART LOCKING BRACKET (0406-00-0860), CART CONSOLE RELEASE LATCH (0367-00-0091), SPRING EXTENSION (0214-00-0216) AND SCREW SHOULDER SCREW (0212-00-0096). THE FSE THEN TESTED THE UNIT FOR PROPER LOCKING / UNLOCKING, THE UNIT WAS THEN CLEARED FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA- AORTIC BALLOON PUMP (IABP) UNIT'S TROLLEY CONSOLE LATCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371898 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