BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17192909 · Received June 23, 2023

    Report

    Report Number
    2249723-2023-02929
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 14, 2023
    Report Date
    June 5, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# 822043;MFG REPORT NUMBER 2249723-2023-02481. REVERT ALL SECTIONS TO BLANK : B. ADVERSE EVENT OR PRODUCT PROBLEM D. SUSPECT MEDICAL DEVICE E. INITIAL REPORTER G. ALL MANUFACTURERS H. DEVICE MANUFACTURERS ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A AUTOFILL FAILURE.

    Description of Event or Problem · 0

    COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4);MFG REPORT NUMBER 2249723-2023-02481.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A AUTOFILL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899947 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.