BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19129959 · Received April 18, 2024

    Report

    Report Number
    2249723-2024-01572
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    August 14, 2023
    Report Date
    January 30, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS), H10. THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE FRONT END BOARD. NORMAL START UP TO CLINICAL MODE, UNABLE TO BOOT TO CLINICAL MODE STARTUP TO SPECIAL MODE, UNABLE TO PERFORM 30PSI CAL AND DRIVE REGULATOR CAL ALSO SUSPECT DRIVE AND VACUUM TRANSDUCER FAULTY (X2 AND X3). REPLACED DRIVE MANIFOLD (0104-00-0032), DRIVE AND VACUUM TRANSDUCER (0682-00-0091-01) UNIT UNABLE TO PERFORM CALIBRATION AND FAILED TO START UP CLINICAL MODE. DID A THOROUGH CHECK ON MAIN BOARDS, PNEUMATIC ASSEMBLY (CONTINUITY AND VISUAL CHECK) FOUND 2 PINS ON J19 PORT OF BACKPLANE BOARD SHORTED TOGETHER REPLACED BACKPLANE BOARD (0670-00-1163). UNIT ABLE TO STARTUP TO CLINICAL MODE, PERFORMED SYSTEM CALIBRATIONS, PERFORMANCE CHECKS AND ENDURANCE RUN ON CLINICAL MODE UNIT TESTED PASS FACTORY SPECIFICATION. THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0670-00-0768, SN: (B)(6) BACKPLANE BOARD. PN: 0104-00-0031, SN: (B)(6) MANIFOLD ASSY, PN: 0682-00-0091-01, SN: (B)(6) PRESSURE TRANSDUCER. PN: 0682-00-0091-01, SN: (B)(6) PRESSURE TRANSDUCER. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF UNIT UNABLE TO POWER UP, ERROR CODES 54 AND 124, UNABLE TO PERFORMED 30PSI CAL, UNIT UNABLE TO PERFORM CALIBRATION, FAILED TO START UP CLINICAL MODE, BACKPLANE BOARD J19 CONNECTOR 2PINS SHORTED. PERFORMED VISUAL INSPECTION OF THESE PARTS RECEIVED AND ALL PARTS LOOKS BE IN GOOD CONDITION. INSTALLED ALL PARTS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TOGETHER AND SEPARATELY TO THE FACTORY SPECIFICATIONS AND THE CARDIOSAVE SERVICE MANUAL. CARDIOSAVE TEST FIXTURE WAS WORKED CORRECTLY AFTER INSTALLED ALL COMPLAINT PARTS. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF UNIT UNABLE TO POWER UP, ERROR CODES 54 AND 124, UNABLE TO PERFORMED 30PSI CAL, UNIT UNABLE TO PERFORM CALIBRATION, FAILED TO START UP CLINICAL MODE, BACKPLANE BOARD J19 CONNECTOR 2PINS SHORTED. ALL COMPLAINT PARTS PASSED TESTING. RETAINING ALL PARTS IN THE FAT DEPT, AS PER PROCEDURE. DUE TO NON-ROHS PN: 0670-00-0768, SN: (B)(6) BACKPLANE BOARD, THIS PART IS NOT GOING BACK TO SUPPLIER FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

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

    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 AN UNRELATED SERVICE BEING PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (GFSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS UNABLE TO POWER UP, ERROR CODE 58 AND 124 WERE FOUND IN THE LOG, X2 AND X3 TRANSDUCER DISPLAYED NO VALUE, AND UNABLE TO PERFORM 30 PSI CAL AND DRIVE REGULATOR CAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539409 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown