BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 18040338 · Received October 31, 2023

    Report

    Report Number
    2249723-2023-04662
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 19, 2023
    Report Date
    September 8, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE STM THAT ENCOUNTERED THE ISSUE REPLACED BOTH HINGES (0105-00-0138-01, 0105-00-0138-02). THE FSE PERFORMED FUNCTIONAL CHECK AND SAFETY CHECK AND COMPLETED THE REPAIR. THE MAQUET FAILURE ANALYSIS AND TESTING DEPT.(FAT) RECEIVED, LEFT HINGE PART NUMBER 0105-00-0138-01 AND RIGHT HINGE 0105-00-0138-02 WITH A REPORTED UNIT FAILURE OF THE TOP SCREEN BEING DIFFICULT TO OPEN. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED BOTH HINGES IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. IT WAS FOUND THAT THE HINGES WERE SEIZED UP AND MADE IT DIFFICULT TO OPEN THE TOP SCREEN. FAT WAS ABLE TO REPLICATE THE REPORTED ISSUE. NO ROOT CAUSE ABLE TO BE DEFINED. RETAINING THE PARTS 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) THE TOP SCREEN IS DIFFICULT TO OPEN. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226418 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown