BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20347570 · Received October 1, 2024

    Report

    Report Number
    2249723-2024-0003996
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 9, 2024
    Report Date
    February 20, 2025
    Manufacturer
    DATASCOPE CORP.
    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

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. SUSPECT DEVICE ORIGINALLY DISTRIBUTED AS CS100, UPGRADED TO CS300 USING CONVERSION KIT. UDI AND PRODUCT INFORMATION PROVIDED FOR ORIGINAL MODEL/CATALOG, AS PER PRODUCT LABELING.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11 2249723-2024-0003996. FIELDS D4 FROM INITIAL EMDR ARE FOR ORIGINAL IABP CS100; HOWEVER, THIS IABP WAS UPGRADED TO A CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V CATALOG 0998-00-3023-53. UDI (B)(4), WHICH WAS REPORTED BY THE CUSTOMER. A GETINGE FIELD SERVICE ENGINEER (FSE) ISOLATED FAILURE TO VIDEO RECEIVER PCB. REPLACED VIDEO RECEIVER PCB. AS A PRECAUTIONARY MEASURE, REPLACED DISPLAY CONTROLLER PCB, LUER FTTING, AND DC TO AC INVERTER PCB. PERFORMED COMPLETE PM WITH FULL CALIBRATION. UNIT PASSES ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS LINES ON THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369579 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown