BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17481503 · Received August 8, 2023

    Report

    Report Number
    2249723-2023-03587
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    August 1, 2023
    Report Date
    November 2, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4) ;MFG REPORT NUMBER 2249723-2023-03593. REVERT ALL SECTIONS TO BLANK : B. ADVERSE EVENT OR PRODUCT PROBLEM, D. SUSPECT MEDICAL DEVICE, E. INITIAL REPORTER, G. ALL MANUFACTURERS, AND H. DEVICE MANUFACTURERS ONLY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINT RECORD BEING CANCELLED AS IT IS A DUPLICATE TO TW# (B)(4);MFG REPORT NUMBER 2249723-2023-03593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT NEEDS POWER MANAGEMENT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320426 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 Unknown