BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 23219365 · Received October 6, 2025

    Report

    Report Number
    2249723-2025-0004125
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 15, 2025
    Report Date
    April 21, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,G6,H2,H11. CORRECTED FIELD: H3.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELD - G4 (PMA/510(K). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THE ECG INPUT CONNECTOR WAS BROKEN. THE UNIT WAS FULLY FUNCTIONAL OTHERWISE STILL GETTING ECG SIGNALS FROM SIMULATOR AND TRAINER WITHOUT ISSUE. THE BROKEN ECG CONNECTOR (0012-00-0976) WAS REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: (B)(4) 7 APR 2026. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-0976 WITH A REPORTED UNIT FAILURE OF A BROKEN INPUT CONNECTOR. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE DAMAGES. SEE ATTACHMENT. POSSIBLE CAUSE IS USER ERROR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS) CORRECTED FIELS: D5. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO INJURY OR HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THE ECG INPUT CONNECTOR WAS BROKEN. THE UNIT WAS FULLY FUNCTIONAL OTHERWISE STILL GETTING ECG SIGNALS FROM SIMULATOR AND TRAINER WITHOUT ISSUE. THE BROKEN ECG CONNECTOR (0012-00-0976) WAS REPLACED. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- INITIAL REPORTER: (B)(6). EVENT SITE NAME: (B)(6). 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 BY GETINGE FIELD SERVICE ENGINEER (GFSE) DURING PM THAT THE ECG CONNECTOR OF CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36497 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53

    Patients

    Seq Age Sex Outcome Treatment
    1