BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V

    MDR report key: 17503141 · Received August 10, 2023

    Report

    Report Number
    2249723-2023-03634
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    August 3, 2023
    Report Date
    January 5, 2024
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 TELEPHONE NUMBER : (B)(6).

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS, E1 PHONE # IS (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP AND WAS ABLE TO CONFIRM THE REPORTED ISSUE. TO FIX THE ISSUE, THE FSE REPLACED THE HYDR CMPNT PUMP ASSY DC KNF. THE FSE COMPLETED FULL CALIBRATION, FUNCTIONAL TESTING, AND SAFETY CHECK TO FACTORY SPECIFICATION. THE UNIT PASSED ALL TESTS PERFORMED AND WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITIONS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP)UNIT CANNOT BE STARTED WHEN IT IS TURNED ON, AND DISPLAYED THE CODE 50. ATTEMPTED TO REBOOT BUT FAILED. THERE WAS NO PATIENT PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP)UNIT CANNOT BE STARTED WHEN IT IS TURNED ON, AND DISPLAYED THE CODE 50. ATTEMPTED TO REBOOT BUT FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP)UNIT CANNOT BE STARTED WHEN IT IS TURNED ON, AND DISPLAYED THE CODE 50. ATTEMPTED TO REBOOT BUT FAILED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474591 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 Unknown