BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16232541 · Received January 24, 2023

    Report

    Report Number
    2249723-2023-00344
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    August 31, 2020
    Report Date
    January 12, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR'S ENGINEER VISITED THE CUSTOMER SITE AND EVALUATED THE IABP UNIT. THE DISTRIBUTOR'S ENGINEER WAS DISPATCHED AND REPLACED THE ECG CABLE ASSEMBLY (0012-00-0976) AND A PAN HEAD SCREW (0212-12-0404). THE DISTRIBUTOR'S PERFORMED TEST AND WAS WORKING OK. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA 584165.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SET-UP, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WHEN THE END USER WAS TRYING TO UNPLUG THE ECG CABLE IT WAS HARD TO PULL OUT, ONCE END USER WAS ABLE TO REMOVE ECG CABLE IT WAS OBSERVED THAT THE ECG INPUT CONNECTOR HAD GOTTEN DAMAGED AND THE CABLE CONNECTOR HAD AN IRREGULAR SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689313 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