BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17419361 · Received July 28, 2023

    Report

    Report Number
    2249723-2023-03430
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 20, 2023
    Report Date
    March 5, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN ORDER TO FIX THE ISSUE, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE TOP LCD (0160-00-0127). THE FSE THEN PERFORMED A FULL PM. THE UNIT PASSED ALL FUNCTIONAL TESTS AND WAS THEN RETURNED TO CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: (B)(4) 22 JAN 2024. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED WITH A REPORTED UNIT FAILURE OF A VERTICAL DEFECT RUNNING THROUGH THE SCREEN. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE DISPLAY IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. POWERED ON AND THE DISPLAY HAD A VERTICAL LINE RUNNING DOWN THE RIGHT SIDE. PLEASE SEE ATTACHMENT. FAT WAS ABLE TO VERIFY THE REPORTED ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6) MEDICAL CENTER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    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 HAD A DEFECT RUNNING THROUGH TOP LCD SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930187 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