BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 23895079 · Received December 26, 2025

    Report

    Report Number
    2249723-2025-0005281
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 30, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107790
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED HYDR CMPNT PUMP ASSY DC KNF. ALL CHECKS MEET USAGE REQUIREMENTS. THE FAULT REPAIR WAS COMPLETE AND THE EQUIPMENT WAS RUNNING NORMALLY.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION, BELOW FIELD ARE ADDED FROM E1- EVENT SITE NAME-(B)(6). EVENT SITE ADDRESS-NO. (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-USE INSPECTION, CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD ELECTRICAL TEST FAILURE ALARM CODE 50. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786616 CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-45 10607567107790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown