BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 16831387 · Received April 28, 2023

    Report

    Report Number
    2249723-2023-02115
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 17, 2023
    Report Date
    October 8, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D5,G2. UPDATED DATA:B4,E1(NAME),G3,G6,H2,H10,H11.

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS; D4(UDI). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY PWM/LO VALUE WAS BELOW THE STANDARD VALUE. THE FSE REPLACED THE FIBER OPTIC ASSEMBLY. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY A TECHNICIAN OF THE FAILURE ANALYSIS AND TESTING DEPARTMENT (FAT) (B)(4) NJ: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED A FIBER OPTIC MODULE ASSEMBLY, WITH A REPORTED OF THE ¿PWM/LO VALUE BELOW THE REFERENCE VALUE¿. PERFORMED VISUAL INSPECTION OF THE FIBER OPTIC MODULE ASSEMBLY PER THE CARDIOSAVE SERVICE MANUAL AND FOUND NO VISUAL DAMAGE AND THE PART LOOKS TO BE IN GOOD CONDITION. INSTALLED INTO THE CARDIOSAVE TEST FIXTURE FOR TESTING OF THE REPORTED PROBLEM. PERFORMED AND TESTED IN ACCORDANCE WITH THE SERVICE MANUAL, IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM. FOUND THAT ALL FUNCTIONS WERE NORMAL. THE TESTS (1 HOUR) DID NOT TRIGGER THE REPORTED PROBLEM OF THE ¿PWM/LO VALUE BELOW THE REFERENCE VALUE¿. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE EXPERIENCED BY THE CUSTOMER. SENDING THE FIBER OPTIC MODULE TO THE SUPPLIER FOR FAILURE ANALYSIS AS PER PROCEDURE. THE ROOT CAUSE SELECTION FOR THIS INVESTIGATION WILL BE ¿NOT CONFIRMED¿ DUE TO THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE.THE FOLLOWING WAS INPUT BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(4) NJ: FAT RECEIVED THE FIBER OPTIC MODULE BACK FROM THE SUPPLIER. THE SUPPLIER TESTED THE BOARD AND NO ABNORMALITIES WERE FOUND. PLEASE SEE ATTACHMENTS FOR FAILURE ANALYSIS PAPERWORK. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. THE FOLLOWING WAS SUBMITTED BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(4) NJ: FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR FIBER OPTIC MODULE. THEY STATED THAT THE PART PASSED WITH NO ISSUES. ROOT CAUSE WILL BE NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    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 UNIT HAD A LOW VALUE AND FAILED THE FIBER OPTICS TEST. THERE IS NO PATIENT INVOLVEMENT REPORTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477148 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown