BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16438016 · Received February 24, 2023

    Report

    Report Number
    2249723-2023-01228
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 26, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D4(VERSION OR MODEL #, CATALOG #, UNIQUE IDENTIFIER (UDI) #), D9, E1 (SITE COUNTRY), E3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSION), H10 ADDITIONAL INFORMATION: E1(EVENT SITE TELEPHONE: (B)(6). IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SCREEN WAS NOT WORKING. A GETINGE FIELD SERVICE ENGINEER (FSE) STATED HE WAS ABLE TO REPRODUCE ISSUE. TO RESOLVE ISSUE REPLACED ASSEMBLY DISPLAY CONTROL BOARD. FUNCTIONAL TESTING AND SAFETY CHECK WAS DONE TO FACTORY SPECIFICATIONS. RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE WAS PATIENT INVOLVED IS UNKNOWN.

    Additional Manufacturer Narrative · 0

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

    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) UNITS SCREEN IS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859601 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown