BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 18618972 · Received January 31, 2024

    Report

    Report Number
    2249723-2024-00394
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 22, 2024
    Report Date
    October 18, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED AND DID NOT CONFIRM THE ISSUE OF THE SCREEN BEING BROKEN. CUSTOMER INFORMED LATER THAT IT WAS A DISTORTED DISPLAY. FSE REPLACED (D012-00-1429) CABLE,DISPLAY TO VIDEO RECEIVER BD TO FIX THE ISSUE. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS PERFORMED. UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE DEVICE IS UPGRADED FROM CS100 TO CS300 THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART WITH A REPORTED UNIT FAILURE OF A DISTORTED DISPLAY. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. NO ISSUES FOUND IN THE DISPLAY. FAT COULD NOT CONFIRM THE REPORTED FAILURE. RETAINING THE PART 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. THEREFORE, THE ROOT CAUSE IS NOT CONFIRMED.

    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 PRIOR TO USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN IS BROKEN. IT WAS LATER CLARIFIED THAT THE DISPLAY WAS DISTORTED.  THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420597 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 N/A.