BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17703419 · Received September 7, 2023

    Report

    Report Number
    2249723-2023-03971
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 30, 2023
    Report Date
    November 11, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS; B4, D9, G3, G6, H2, H3, H4, H6, H11. CORRECTED FIELDS; D4(UDI). THE SPEAKER WAS INOPERATIVE. THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE BACKPLANE BOARD (0670-00-1163). THE FSE PERFORMED A COMPLETE PM WITH FULL CALIBRATION, FUNCTIONAL TESTING, AND SAFETY CHECKS TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY A TECHNICIAN OF THE FAILURE ANALYSIS AND TESTING DEPARTMENT (FAT) WAYNE, NJ: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED A BACK PLANE BOARD, WITH A REPORTED FAILURE OF ¿NO AUDIO POWER UP FOR SYSTEM FAILURE TEST¿. PERFORMED VISUAL INSPECTION PER THE CARDIOSAVE SERVICE MANUAL AND FOUND NO VISUAL DAMAGE AND THE PART LOOKS TO BE IN GOOD CONDITION. INSTALLED INTO CARDIOSAVE TEST FIXTURE FOR TESTING OF THE REPORTED PROBLEM. PERFORMED AND TESTED (1 HOUR) IN ACCORDANCE WITH 2100067 THE CARDIOSAVE SERVICE MANUAL. ALL FUNCTIONS WERE NORMAL. THE TESTS DID NOT TRIGGER THE REPORTED PROBLEM. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE EXPERIENCED BY THE CUSTOMER. SENDING THE BACK PLANE BOARD 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) WAYNE, NJ: FAT RECEIVED BACK PLANE BOARD BACK FROM THE SUPPLIER. THE SUPPLIER TESTED THE BOARD AND NO ABNORMALITIES WERE FOUND. THIS INVESTIGATION IS NOW COMPLETE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD NO AUDIO POWER UP, SYSTEM FAILURE SPEAKER WAS INOPERATIVE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121590 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