BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 13482659 · Received February 8, 2022

    Report

    Report Number
    2249723-2022-00245
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 18, 2022
    Report Date
    March 1, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING OF ACTUAL/SUSPECTED DEVICE (10): A GETINGE FIELD SERVICE ENGINEER EVALUATED THE IABP AND DISCOVERED WATER DAMAGE DUE TO USER ERROR. THE REPAIR OF THE IABP IS ONGOING A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE FOUND WATER ON MULTIPLE BOARDS. THE FSE REPLACED THE PNEUMATIC MODULE ASSEMBLY (0997-00-1178), PNEUMATICS INTERFACE BOARD (0670-00-1167), AND THE POWER MANAGEMENT BOARD (0670-00-1162). THE FSE PERFORMED A FULL CALIBRATION AND TESTED THE UNIT. THE UNIT WORKED TO THE MANUFACTURER¿S SPECS. THE IABP WAS CLEARED FOR CLINICAL USE AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WOULD NOT TURN ON. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THIS EVENT OCCURRED OR IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WOULD NOT TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549848 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown