BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 22018867 · Received May 14, 2025

    Report

    Report Number
    2249723-2025-0002194
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 29, 2025
    Report Date
    July 23, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9 (RETURN TO MANUFACTURER DATE), G1, G3, G6, H2, H3, H6 (COMPONENT CODE, INVESTIGATION FINDINGS , INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11 A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED DISPLAY TO VIDEO RECEIVER BOARD CABLE (0012-00-1429). THE FOLLOWING INVESTIGATION WAS PERFORMED BY ANGEL RODRIGUEZ, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1429 WITH A REPORTED UNIT FAILURE OF A SCREEN MALFUNCTION. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART INTO CS300 TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CS300 SERVICE MANUAL PART NUMBER 0070-00-0689 REV W. NO FAILURE CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: D9 (RETURN TO MANUFACTURE DATE).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: D9 (RETURN TO MANUFACTURE DATE REVERTED TO BLANK), H6 (COMPONENT CODES).

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING USE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD SCREEN GOES OUT. SCREEN TURNED BLACK. THERE WAS NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880929 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male UNKNOWN.