BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 21319975 · Received February 6, 2025

    Report

    Report Number
    2249723-2025-0000558
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 20, 2025
    Report Date
    April 3, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    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

    A GETINGE FIELD SERVICE ENGINEER FSE REPLACED THE DISPLAY, MOUNTING PLATE, CABLE, VIDEO RECEIVER TO LCD AND DISPLAY W/ RTV BEAD SEA. ALL FUNCTIONAL AND SAFETY CHECKS PERFORMED TO MEET FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, D9, G3, G6, H1, H2., H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE, DISPLAY (0065-00-0391), MOUNTING PLATE (0406-00-0916), CABLE, VIDEO RECEIVER TO LCD (0012-00-1747) AND DISPLAY W/ RTV BEAD SEA (0160-00-0113). ALL FUNCTIONAL AND SAFETY CHECKS PERFORMED TO MEET FACTORY SPECIFICATIONS THE FOLLOWING WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT.THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: DISPLAY W/RTV BEAD SEA,MOUNTAIN PLATE, NEC DISPLAY, MERITEC CABLE, VIDEO RECEIVER TO LCD.THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF SCREEN DAMAGED. PERFORMED VISUAL INSPECTION OF THIS PARTS RECEIVED AND FOUND SCRATCHES ON 10.4¿¿ DISPLAY W/RTV BEAD SEA, MOUNTAIN PLATE WAS BENDED, AND CABLE LOOKS IN GOOD CONDITION. THE FAT DEPT. VERIFIED THE FAILURE MESSAGE OF DAMAGED FOR 10.4¿¿ DISPLAY SCREEN AND MOUNTAIN PLATE. PLEASE SEE ATTACHED PICTURES.THE FAT DEPT. COULD NOT VERIFY THE FAILURE MESSAGE FOR CABLE, VIDEO RECEIVER TO LCD.RETAINING ALL COMPLAINTS PARTS IN THE FAT DEPT. PER PROCEDURE.ROOT CAUSE GRID: USER- OPERATIONAL CONTEXT & NOT CONFIRMED.THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE IS LOSS OF DISPLAY DUE TO AGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS SCREEN IS DAMAGED. THERE WAS NO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248688 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown