BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 17221783 · Received June 28, 2023

    Report

    Report Number
    2249723-2023-03008
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 20, 2023
    Report Date
    April 9, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    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

    THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE RIGHT DISPLAY HINGE (0105-00-0138-02) AND THE LEFT DISPLAY HINGE (0105-00-0138-01). THE FSE PERFORMED FUNCTIONAL AND SAFETY CHECKS. THE MAQUET FAILURE ANALYSIS AND TESTING DEPT.(FAT) RECEIVED HINGES PART NUMBER 0105-00-0138-01 AND 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 PARTS TO BE IN A WORN CONDITION. THE FAT INSTALLED THE HINGES IN CARDIOSAVE TEST FIXTURE AND TESTED THEM TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. IT WAS FOUND THAT THE TOP SCREEN WAS DIFFICULT TO OPEN DUE TO THE HINGES BEING SEIZED UP. FAILURE WAS REPLICATED BUT NO ROOT CAUSE DEFINED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 TELEPHONE NUMBER : (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    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 TOP SCREEN WAS DIFFICULT TO OPEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321939 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown