BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 17161950 · Received June 20, 2023

    Report

    Report Number
    2249723-2023-02862
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    June 9, 2023
    Report Date
    March 7, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE UNIT AND VERIFIED UNIT HAS INTERMITTENT LINES ACROSS THE SCREEN. THE FSE STATED THAT THE ISSUE CHANGES AS YOU PHYSICALLY MANIPULATE THE DISPLAY. TO FIX THE ISSUE THE FSE REPLACED LCD SCREEN AND ALL ASSOCIATED COMPONENTS. THE FSE THEN PERFORMED ALL FULL FUNCTIONAL TEST TO FACTORY SPECIFICATIONS. THE IABP PASSED ALL TESTS PERFORMED AND WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER: 0012-00-1429 PN:0012-00-1428 PN: 0406-00-0818 PN: 0160-00-0113 THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PN: 0160-00-0113 TO HAVE LINES ACROSS THE SCREEN. THE REST OF THE PARTS WERE IN GOOD CONDITION. THE FAT INSTALLED THE PARTS INTO CS300 TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CS300 SERVICE MANUAL. NO ISSUES WERE FOUND WITH THE PARTS DURING TESTING. THE DISPLAY FULLY POWERED ON AND FUNCTIONED PROPERLY. ANY MANIPULATION OF THE DISPLAY DID NOT AFFECT THE IMAGE. FAT DID NOT CONFIRM THE ISSUE OF THE SCREEN FLASHING AND NOT COMING UP. THE MAIN ISSUE SEEMS TO BE THE SCRATCHES ON THE LCD SCREEN OF PN: 0160-00-0113. FAT WAS ABLE TO VERIFY THE REPORTED UNIT FAILURE OF LINES ACROSS THE SCREEN. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS FLASHING AND DOES NOT COME UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) SCREEN IS FLASHING AND DOES NOT COME UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015009 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| UNKNOWN.