BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 18713320 · Received February 15, 2024

    Report

    Report Number
    2249723-2024-00665
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    February 7, 2024
    Report Date
    December 19, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT DETAILS: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED COILED CABLE (0012-00-1422) AND SCREEN STILL DISTORTED. REPLACED THE DISPLAY CABLE AND SCREEN STILL DISTORTED. REPLACED KEYPAD CONTROLLER AND SCREEN STILL DISTORTED. REPLACED THE DISPLAY AND SCREEN POPULATED WITH NO PROBLEMS. VERIFIED UNIT CALIBRATED AND PASSES ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE REPORTED PROBLEM WAS NOT DUPLICATED OR VERIFIED. PRODUCT PASSED ALL FUNCTIONAL/SAFETY TESTING. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: DISPLAY CABLE, KEYPAD CONTROLLER, DISPLAY AND SCREEN. PARTS RECEIVED WITH A REPORTED FAILURE OF A DISPLAY ISSUE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED COILED CABLE INTO CS300 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO ISSUE CONFIRMED. THE FAT INSTALLED DISPLAY CABLE INTO CS300 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO ISSUE CONFIRMED. THE FAT INSTALLED KEYPAD CONTROLLER INTO CS300 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO ISSUE CONFIRMED. THE FAT INSTALLED DISPLAY INTO CS300 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO ISSUE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS HAVING DISPLAY ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS HAVING DISPLAY ISSUES. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086832 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown