BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16583255 · Received March 21, 2023

    Report

    Report Number
    2249723-2023-01563
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 10, 2023
    Report Date
    February 28, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND FOUND WHEEL ASSEMBLY WAS BENT. TO FIX THE ISSUE, THE FSE REPLACED THE WHEEL ASSEMBLY 997-00-0588, AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED FOR CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BY CUSTOMER THAT THEY BELIEVE , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS DAMAGED BY A CREW MEMBER WHILE ATTEMPTING TO LOAD THE PUMP INTO THE AIRCRAFT PRIOR TO TRANSPORT, THE SMALL WHEEL IS BENT AND WILL NOT FULLY EXPAND WITHOUT MANUALLY PULLING IT OUTWARDS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8119 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