BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 19529161 · Received June 13, 2024

    Report

    Report Number
    2249723-2024-02513
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    June 3, 2024
    Report Date
    March 6, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    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

    UPDATED FIELD: B4, D8, D9,G3, G6, H2, H3, H6 ( (COMPONENT CODE, HEALTH EFFECT CODE, INVESTIGATION FINDINGS , INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION IT WAS BEING OBSERVED THAT THE DISPLAY WAS BEING DISTORTED WHEN THE DEVICE WAS BEING POWERED ON. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION FSE HAD REPLACED THE DISPLAY RIBBON CABLE) WHICH HAS RESOLVED THE ISSUE. THE UNIT HAD PASSED ALL THE CALIBRATION , FUNCTIONAL AND SAFETY TESTS WERE BEING PERFORMED. THE UNIT WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THERE WAS NO INVOLVEMENT OF THE PATIENT DURING THIS INCIDENT. THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1429 DISPLAY CABLE 02 46_MERITEC WITH A REPORTED UNIT FAILURE OF DISPLAY ISSUES, BLACK SCREEN AFTER BOOTING. 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 PART NUMBER 0012-00-1429 DISPLAY CABLE 02 46_MERITEC INTO THE CS100 TEST FIXTURE SERIAL NUMBER (B)(6)-K3 AND TESTED THE CABLE TO FACTORY SPECIFICATIONS PER THE CS100 SERVICE MANUAL PART NUMBER 0070-00-0528-01 REV. THE FAT DEPT. PROCEEDED TO BOOT THE CS100. AFTER BOOTING UP, THE FAT DEPT., OBSERVED NORMAL VIDEO ON THE DISPLAY. THE FAT PROCEEDED TO BOOT THE UNIT UP A NUMBER OF TIMES, AND THE FAT DEPT. COULD NOT REPLICATE THE COMPLAINT OF A BLACK SCREEN AFTER BOOTING. THE CABLE PASSED TESTING. RETAINING THE CABLE IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV.

    Additional Manufacturer Narrative · 0

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

    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 THAT BEFORE USE, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAS DISPLAY ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185418 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown