BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 18608366 · Received January 30, 2024

    Report

    Report Number
    2249723-2024-00370
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 19, 2024
    Report Date
    October 16, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) SUCCESSFULLY COMPLETED A FUNCTIONAL CHECK WITH TESTING CATHETER AND TRAINER WITHOUT ISSUE UPON INITIALLY TESTING UNIT. SUCCESSFULLY OBTAINED ECG AND BP WAVEFORMS WITH TRAINER WITHOUT ISSUE. FSE CONFIRMED BROKEN ECG CONNECTOR. REPLACED BROKEN ECG CONNECTOR, AND WHILE IN THE SAME AREA, REPLACED BP CONNECTOR AS WELL AS A PRECAUTION. POST REPLACING AFOREMENTIONED PARTS, SUCCESSFULLY COMPLETED A FULL FUNCTION CHECK WITHOUT ISSUE. UNIT CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. SERVICE COMPLETED. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. PLEASE REFER TO THE ROOT CAUSE EVALUATION FIELD FOR DETAILS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0012-00-0977 , PN 0012-00-0976. PARTS WERE RECEIVED WITH A REPORTED FAILURE OF THE ECG PORT DAMAGED. BP CABLE WAS REPLACED AS PRECAUTION. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND PN 0012-00-0976 TO HAVE DAMAGE ON THE CONNECTOR. PLEASE SEE ATTACHMENT. CONFIRMED REPORTED ISSUE WITH PART. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED. THE FAT INSTALLED PART NUMBER PN 0012-00-0977 INTO CS100 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS100 SERVICE MANUAL PART NUMBER 0070-00-0528-01 REV AD. NO ISSUES CONFIRMED FOR THIS PART. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    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

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING DAILY CHECKS ,THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) ECG PORT DAMAGED, EXTERNAL COSMETIC DAMAGE DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2550934 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown