BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21190014 · Received January 20, 2025

    Report

    Report Number
    2249723-2025-0000266
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 2, 2025
    Report Date
    February 18, 2025
    Manufacturer
    DATASCOPE CORP.
    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 GETINGE FIELD SERVICE ENGINEER (FSE) STATES, CUSTOMER STATED THAT TOP DISPLAY ON CARDIOSAVE IABP WAS BEHAVING ERRATICALLY. THE FSE EVALUATED THE UNIT AND VERIFIED TOP SCREEN TO BE FLICKERING. THE FSE REPLACED TOP DISPLAY (0334-00-1810-01) AND PERFORMED ALL FUNCTIONAL AND SAFETY TEST.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) TOUCHSCREEN DISPLAYED A WHITE SCREEN. NO PATIENT INVOLVEMENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644888 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown