BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17342844 · Received July 18, 2023

    Report

    Report Number
    2249723-2023-03221
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    July 6, 2023
    Report Date
    October 9, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS; D4(UDI). THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE UPPER PANEL. THE FSE PERFORMED A COMPLETE PM WITH FULL CALIBRATION. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(4), NJ: THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED AN UPPER PANEL, WITH A REPORTED UNIT FAILURE OF THE FIBER OPTIC DOOR NOT STAYING CLOSED. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A FAULTY FIBER OPTIC DOOR. FAT WAS ABLE TO VERIFY THE REPORTED ISSUE WITH PROBABLE ROOT CAUSE BEING EXPECTED WEAR AND TEAR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FIBER OPTIC DOOR FALLING OPEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872133 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