BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V

    MDR report key: 16853480 · Received May 2, 2023

    Report

    Report Number
    2249723-2023-02171
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 20, 2023
    Report Date
    February 12, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107684
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED DISPLAY DISPLAY FAILURE OCCURS, BUT IT DOES NOT REOCCUR AFTER THAT. PREVENTIVELY HE REPLACED CABLE DISPLAY (0012-00-1429). THE FSE PERFORMED ALL FUNCTIONAL SAFETY TESTS TO FACTORY SPECIFICATIONS. UNIT IS CLEAR FOR CLINICAL USE AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BAD DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247743 CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-65 10607567107684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown