BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 15846038 · Received November 22, 2022

    Report

    Report Number
    2249723-2022-02994
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 10, 2022
    Report Date
    July 5, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    A GETINGE FIELD SERVICE TECHNICIAN (FST) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE SHIFTED THE HELIUM TANK AND CORRECTED THE SYSTEM TIME/DATE. THE FSE REPLACED THE AC LINE CORD (0012-00-0886-0) AS THE ONE BEING USED WAS NOT MEDICAL GRADE. IT WAS THE WRONG GAUGE AND WAS NOT AN OEM CABLE. THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM). ALL TESTS WERE WITHIN RANGE. THE IABP WAS CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN HOUSE BIOMED DISCOVERED, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT NOTIFIED MAINTENANCE CODE #5 AND LOST SYSTEM DATE AND TIME. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807227 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown