BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16416948 · Received February 22, 2023

    Report

    Report Number
    2249723-2023-01217
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 29, 2023
    Report Date
    August 15, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS BEING CANCELLED AS IT IS RELATED TO A LOGISTICS ISSUE DUE TO THE AVAILABILITY OF REPLACEMENT PARTS AND ONGOING SUPPLIER ISSUES. THERE WAS NO REPORTED MALFUNCTION OF ANY PARTICULAR IABP UNIT. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RECORD IS BEING DUE TO LOGISTICS ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IS HAVING ON GOING SUPPLY ISSUES, INABILITY TO GET CATHETERS, REPLACEMENT PARTS, OR EMERGENT RENTAL EQUIPMENT WHEN IABP MACHINES GO DOWN, TWO MACHINES REQUIRE SERVICING , NO RENTALS AVAILABLE AND 2-3 WEEKS FOR A TECHNICIAN. PER VOLUNTARY MEDWATCH REPORT # MW5114621 RECEIVED FROM FDA ON 10FEB2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228387 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.