BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16831386 · Received April 28, 2023

    Report

    Report Number
    2249723-2023-02114
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 17, 2023
    Report Date
    March 11, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CS300 INTRA-AORTIC BALLOON PUMP (IABP) FACING LOW VACUUM FAILURE. A GETINGE FIELD SERVICE ENGINEER (FSE) VISITED AND SWAPPED THE MOTOR CONTROL BOARD BUT DID NOT FIX DISCREPANCY AND IS GOING TO REMAIN INSTALLED IN UNIT. AFTER FURTHER TROUBLESHOOTING HE FOUND THE COMPRESSOR AND MAIN PCB NEEDS TO BE CHANGED. REPLACED THE HYDRAULIC COMPONENT PUMP ASSEMBLY DC KNF (D102-00-0001), PNEUMATIC COMPONENT COUPLE .25FL BULK HD (D103-00-0373), PNEUMATIC COMPONENT NIP .25 FLOW BULK HD (D103-00-0375), HOSE ASSEMBLY #5 VACUUM V1 THRU V6 (D004-00-0058), TUBING ASSEMBLY VACUUM V7 V8 (D004-00-0062), 2500 PREVENTIVE MAINTENANCE HR KIT (D040-00-0146), IABP PCB MAIN BOARD (D670-00-0788), PCB MOTOR CONTROL (D670-00-1159). UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. RETURNED TO CUSTOMER AND CLEARED FOR USE. PATIENT INVOLVEMENT 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) DISPLAYING LOW VACUUM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477147 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 NA Unknown UNKNOWN.