BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 13548768 · Received February 17, 2022

    Report

    Report Number
    2249723-2022-00316
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    January 21, 2022
    Report Date
    July 31, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE/10: A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE DETERMINED THAT THE POWER SUPPLY WAS DEFECTIVE. TO FIX THE ISSUE, THE FSE REPLACED THE POWER SUPPLY, AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: D1, D4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE REPORTED THAT THE POWER SUPPLY WAS DEFECTIVE SO THE FSE REPLACED THE POWER SUPPLY FROM COMPANY STOCK TO HOSPITAL UNDER CMC AND THE MACHINE WAS WORKING FINE. THE FSE COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A ROUTINE CHECK THE CS300 INTRA- AORTIC BALLOON PUMP (IABP) UNIT WILL NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999016 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-55 N/A 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown