BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16229304 · Received January 23, 2023

    Report

    Report Number
    2249723-2023-00327
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    August 25, 2020
    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
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE IABP AND REPORTED THAT DISPLAY HAD LINES TOWARDS THE BOTTOM. THE STM REPLACED MYLAR CABLE (0012-00-1747) AND COILED CABLE (0012-00-1422). SUBSEQUENTLY, PERFORMED A FULL FUNCTION AND CALIBRATION CHECK. THE IABP WAS CLEARED FOR USE AND RETURNED TO CUSTOMER. 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 BEFORE USE, THE DISPLAY IN THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WHILE STILL VISIBLE, HAD LINES GOING DOWN THE BOTTOM OF THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717139 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