BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 20273082 · Received September 20, 2024

    Report

    Report Number
    2249723-2024-0003864
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    September 2, 2024
    Report Date
    October 23, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) ON HAS CHECKED AND FOUND THAT THE UNIT NEEDS REPLACEMENT OF CABLE, DISPLAY D012-00-1429 SPARE PART AS SOON AS POSSIBLE. THE FSE LATER HAS REMOVED THE CABLE, DISPLAY AND REFIXED IT PROPERLY AND THE DISPLAY IS FINE. UNIT IS KEPT UNDER OBSERVATION. THEN THE FSE REMOVED THE CABLE, DISPLAY AND REPLACED WITH A NEW CABLE, DISPLAY D012-00-1429. NOW THE DISPLAY IS WORKING SATISFACTORILY. UNIT IS HANDED OVER TO THE CUSTOMER IN GOOD WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE CHECK ,THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) SHOWS DISPLAY IS FLICKERING ISSUE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554593 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-55 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.