BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17500265 · Received August 10, 2023

    Report

    Report Number
    2249723-2023-03603
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 23, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MFG REPORT 2249723-2023-03603 IS BEING CANCELLED. IT IS A DUPLICATE OF COMPLAINT OT 871765 / MFG REPORT NUMBER 2249723-2023-03725.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THIS MFG REPORT 2249723-2023-03603 IS BEING CANCELLED. IT IS A DUPLICATE OF COMPLAINT OT 871765 / MFG REPORT NUMBER 2249723-2023-03725.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) CUSTOMER CALLED REGARDING A PUMP IN THE CVOR WOULD NOT BOOT UP PAST THE BLUE SCREEN. THE PATIENT WENT INTO THE CVOR ON THE PUMP, DURING THE CASE THE PUMP WAS POWERED OFF AND WHEN IT WAS RESTARTED AFTER THE CASE SHE NOTED A HIGH PITCHED SCREAM AND IT WOULDN'T GET PAST THE BLUE SCREEN. CUSTOMER WAS CONCERNED BECAUSE ALL THE BACKUP PUMPS WERE WAITING REPAIR AND STATED THE PATIENT WAS ABLE TO COME OFF OF THERAPY IN THE ICU, THEY USED THAT PUMP FOR THE OR PATIENT AND NO OTHER PUMPS WERE AVAILABLE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062768 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 77 YR Male