BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 16223119 · Received January 23, 2023

    Report

    Report Number
    2249723-2023-00278
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    January 8, 2023
    Report Date
    January 30, 2025
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107790
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION COMPLETE E1(SITE NAME) - HUAZHONG UNIVERSITY OF SCIENCE TONGJI HOSPITAL, TONGJI MEDICAL COLLEGE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: E1(VENT SITE POSTAL CODE: (B)(6)). A GETINGE FIELD SERVICE ENGINEER CONFIRMED SINCE THE CUSTOMER'S REPAIR PLAN AND PRICE HAVE NOT YET BEEN CONFIRMED, HIS REPAIR WORK HAS NOT BEEN CARRIED OUT. THE EQUIPMENT IS CURRENTLY OUT OF SERVICE AND AWAITING REPAIR."

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WHEN THE MACHINE IS STARTED, THE EQUIPMENT REPORTS A LOOP LEAKAGE, ENTERS THE MAINTENANCE MODE FOR TESTING, AND LEAKS ARE FOUND. THE PRESSURE CANNOT BE MAINTAINED, AND IT IS JUDGED THAT MAINTENANCE IS NEEDED. AFTER REPLACING THE 5000-HOUR MAINTENANCE KIT, ALL PARAMETERS ARE RETESTED AND NORMAL, CONFIRMING THAT THE FAULT HAS BEEN REPAIRED AND CAN BE USED CLINICALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) JAD A LOOP AIR LEAKAGE ALARM. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432776 CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3013-45 10607567107790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown