BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM

    MDR report key: 11016411 · Received December 16, 2020

    Report

    Report Number
    2249723-2020-02166
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 26, 2020
    Report Date
    February 15, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107745
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:E1(EVENT SITE STATE -KARNATAKA) A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. DISPLAY P/N D012-010-1059, WAS REPLACED WITH S/N 1832. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER FOR RETURN TO CLINICAL SERVICE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WE WILL REPORT ACCORDINGLY IF IT BECOMES AVAILABLE. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480665 CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-UC-3013-53 NA 10607567107745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown