BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18637286 · Received February 3, 2024

    Report

    Report Number
    2249723-2024-00446
    Event Type
    Malfunction
    Date Received
    February 3, 2024
    Date of Event
    January 25, 2024
    Report Date
    November 7, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER FSE WAS DISPATCHED TO THE SITE TO EVALUATE THE UNIT. HE REPLACED SOLENOID DRIVER BOARD. COMPLETE PM PERFORMED WITH FULL CALIBRATION. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS.9V DAUGHTER BOARD BATTERY AND QUICK DISCONNECT O-RING REPLACED. THE FAILURE ANALYSIS AND TESTING DEPT. REPORTED UNIT FAILURE OF A FAULT CODE #118 - CRITICAL ERROR DETECTED IN HARDWARE WATCHDOG CIRCUIT. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD IN CARDIOSAVE TEST AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL . TESTED FOR 30 MINUTES WITH NO ISSUES OR FAULT CODES APPEARING. FAT COULD NOT CONFIRM THE REPORTED ISSUE. SENDING THE BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS .THE SUPPLIER EVALUATION STATES THE FOLLOWING: PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND . BOARD WAS RE-TESTED AT FCT RESULT: PASSED RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF THE FAT DEPT WILL RETAIN THIS PART AS . THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A FAULT CODE # 118 - ¿SOL WDT FAIL ¿ - A CRITICAL ERROR DETECTED IN THE HARDWARE WATCH DOG CIRCUIT ON THE SOLENOID DRIVER BOARD RECORDED MULTIPLE TIMES IN LOGS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558344 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.