BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 19184671 · Received April 25, 2024

    Report

    Report Number
    2249723-2024-01679
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 15, 2024
    Report Date
    January 22, 2025
    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

    UPDATED FIELDS: B4, D1, D4 (CATALOG, VERSION OR MODEL, UDI), H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER FSE EVALUATED AND RESOLVED THE ISSUE BY REPLACING FIBER OPTIC ASSY. FSE THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0997-00-1169, SN: (B)(6) FISO FIBER OPTIC ASSY ROHS THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF MAINTENANCE REQUIRED ALARM OCCURRED. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED FIBER OPTIC ASSY INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PN: 0070-00-0639 REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF MAINTENANCE REQUIRED ALARM. THE FAT DEPT PUMPED THE UNIT AND DID NOT OBSERVE ALARM ON SCREEN. FIBER OPTIC ASSY PASSED TESTING. SENDING FIBER OPTIC ASSY BOARDS TO THE RESPECTIVE SUPPLIER FOR FURTHER INVESTIGATION PER PROCEDURE 0002-07-D008 REV AQ. PN: 0992-00-1017, SN: (B)(6) FISO (PART OF FIBER OPTIC ASSY.). PN: 0670-00-1160, SN: (B)(6) (PART OF FIBER OPTIC ASSY.). THE FOLLOWING WAS SUBMITTED BY (B)(6) TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT FAT WAYNE NJ. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN: 0670-00-1160. THEY STATED THAT THE PART PASSED WITH NO ISSUES. ROOT CAUSE FOR THIS PART IS NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AR. THE NONCONFORMANCE'S WITH THE RETURNED COMPONENTS WERE NOT IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. STILL AWAITING ONE PART FROM THE SUPPLIER. THE FOLLOWING WAS SUBMITTED BY (B)(6) TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT FAT WAYNE NJ. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN: 0992-00-1017 SN: (B)(6) FISO. THEY STATED THE PART PASSED WITH NO ISSUES. PROBABLE ROOT CAUSE FOR THIS PART IS NOT CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: 0002-07-D008 REV. AR. THE NONCONFORMANCE'S WITH THE RETURNED COMPONENTS WERE NOT IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    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 PRE-DELIVERY INSPECTION OF THE NEW CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BY A GETINGE FIELD SERVICE ENGINEER (GFSE), THE OPTICAL FIBER MODULE MAINTENANCE REQUIRED ALARM OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659629 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 N/A.