BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 16576944 · Received March 20, 2023

    Report

    Report Number
    2249723-2023-01539
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 21, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    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

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF SCREEN IS NOT WORKING. NO PATIENT INVOLVED. A GETINGE FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE LCD FAILURE NOT WORKING REPLACED DISPLAY W/ RTV BEAD SEA AS AN PRECAUTIONARY MEASURE AND PERFORMED PASSING FULL FUNCTIONAL TEST . UNIT RETURNED TO CLINICAL USE. 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 DISPLAY W/ RTV BEAD SEA DISPLAY WITH A REPORTED UNIT FAILURE OF BLANK SCREEN UPON BOOTUP.THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION.THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED DISPLAY W/ RTV BEAD SEA DISPLAY INTO THE CS300 TEST FIXTURE AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV. W.THE FAT PROCEEDED TO BOOT UP THE CS300 TEST FIXTURE. WHEN THE SYSTEM BOOTED UP THE FAT OBSERVED THAT THE DISPLAY WAS BLANK. THE FAT WAS ABLE TO REPLICATE THE FAILURE THAT THE CUSTOMER EXPERIENCED.THE DISPLAY FAILED TESTING.RETAINING THE DISPLAY IN THE FAT PER PROCEDURE NUMBER (B)(4) REV.AQ THE NON CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361260 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0479-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown