BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 24826889 · Received April 9, 2026

    Report

    Report Number
    2249723-2026-0002116
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 9, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT ONSITE AND IDENTIFIED THAT THE ISSUE WAS RELATED TO EXPIRED SAFETY DISK (0997-00-0985-15) AND 5000HR MAINTENANCE KIT (0040-00-0147). THE SAFETY DISK AND MAINTENANCE KITS WERE REPLACED, AFTER WHICH THE DEVICE UNDERWENT FUNCTIONAL AND SAFETY TESTING, ALL OF WHICH PASSED AND MET FACTORY SPECIFICATIONS. THE REPLACED COMPONENTS WERE RETAINED BY THE CUSTOMER AND NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAYED AN ¿AUTOMATIC CHARGING FAILED¿ ALARM, RENDERING THE DEVICE UNUSABLE. NO HARM OR INJURIES WERE REPORTED. A BACKUP DEVICE WAS PROVIDED TO CONTINUE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885800 CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-45 - CS100 CHINESE 10607567107790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown