BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 17006446 · Received May 25, 2023

    Report

    Report Number
    2249723-2023-02532
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 16, 2023
    Report Date
    February 29, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL CUSTOMER CONTACT INFORMATION: NAME: (B)(6),OCCUPATION: BIOMEDICAL ENGINEER, (B)(6). IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD FRAYED AC POWER CORD. IT WAS RESOLVED BY REPLACING CABLE AC LINE POWER CORD (012-00-0886-01). COMPLETE CHECKOUT AND CHECKLIST HAS BEEN PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNITS POWER CABLE CASING STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640035 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 NA Unknown N/A.