BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18908867 · Received March 14, 2024

    Report

    Report Number
    2249723-2024-01089
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    March 5, 2024
    Report Date
    November 21, 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) CONFIRMED SYSTEM FAILURE UPON BOOT UP. FSE CONFIRMED FAULT CODE#118 SOL WDT FAIL IN THE ERROR LOGS. A CRITICAL ERROR DETECTED IN THE HARDWARE WATCH DOG CIRCUIT ON THE SOLENOID DRIVER BOARD. SOLENOID CONTROL PCBA WAS REPLACED. DEVICE POWERED ON SUCCESSFULLY WITHOUT ISSUE. COMPLETE PREVENTIVE MAINTENANCE (PM) PERFORMED WITH FULL CALIBRATION. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THERE WAS NO PATIENT INVOLVEMENT. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. PLEASE REFER TO THE ROOT CAUSE EVALUATION FIELD FOR DETAILS.THE FOLLOWING INVESTIGATION WAS PERFORMED BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED A SOLENOID CONTROL BOARD WITH A REPORTED UNIT FAILURE OF THE SYSTEM NOT BOOTING UP. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. COULD NOT VERIFY THE FAILURE. SENDING THE BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: THE FAT DEPT. RECEIVED SOLENOID CONTROL BOARD FROM THE SUPPLIER. SUPPLIER INVESTIGATION: PERFORMED VISUAL CHECK AND NO ABNORMALITY FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED. RESULT AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. RETAINING THIS BOARD IN THE FAT DEPT. PER PROCEDURE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT IDENTIFIED. 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 (D1, D2, D3, D4, G4, H5).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM BOOT UP FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186041 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.