BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 19042109 · Received April 4, 2024

    Report

    Report Number
    2249723-2024-01390
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 26, 2024
    Report Date
    October 22, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER (FSE) STATED THAT DURING THE PERFORMANCE OF FA 245 - CARDIOSAVE 2023-001 AND FA 113-180-246 FSCA 2019-001-C/2021-001-C/FSCA 2023-002-C THEY BREAK DOWN DIFFERENT COMPONENTS DUE TO TECHNICAL INTERVENTION ON THE DEVICE AND REALIZED THAT THE EQUIPMENT WAS GIVING US AN F7 ERROR IN THE LED CODES. ONCE THE COMPONENTS IN THE EQUIPMENT WERE REPLACED PCBA, CARDIOSAVE ROHS POWER MANAGEMENT, PCBA, EXEC PROCESSOR, PCB,FRONT END,ROHS, KIT, DISPLAY MONITOR TO VIDEO GEN BOARD, DRIVE MANIFOLD ASSEMBLY, THE SOFTWARE COULD BE INSTALLED, CALIBRATED AND THE EQUIPMENT OPERATIONAL FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELDS: H6(MEDICAL DEVICE ¿ PROBLEM CODE). A GETINGE FIELD SERVICE ENGINEER (FSE) STATED THAT DURING THE PERFORMANCE OF FA 245 - CARDIOSAVE 2023-001 AND FA 113-180-246 FSCA 2019-001-C/2021-001-C/FSCA 2023-002-C DIFFERENT COMPONENTS BROKEN DOWN DUE TO TECHNICAL INTERVENTION ON THE DEVICE. FSE REPLACED POWER MANAGEMENT, EXECUTIVE PROCESSOR, FRONT END, DISPLAY MONITOR TO VIDEO GEN BOARD KIT AND DRIVE MANIFOLD ASSEMBLY. ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS PERFORMED. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: SWEMCO POWER MANAGEMENT BOARD, HTC EXECUTIVE PROCESSOR BOARD, HTC EXECUTIVE PROCESSOR BOARD, NBS FRONT END BOARD, KIT, VIDEO GEN. BOARD TO DISPLAY MONITOR BOARD, NBS VIDEO GEN. BOARD (PART OF KIT), SWEMCO DISPLAY MONITOR BOARD (PART OF KIT), MWTS CABLE ASSY, (PART OF KIT). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF SOFTWARE WOULD NOT BE ABLE TO INSTALL AND COMPONENT BROKEN. PERFORM VISUAL INSPECTION OF THESE PARTS RECEIVED AND ALL PARTS LOOKS TO BE IN GOOD CONDITION. INSTALLED ALL PARTS INTO THE CARDIOSAVE TEST FIXTURE SN (B)(6) AND TESTED SEPARATELY AND TOGETHER TO THE FACTORY SPECIFICATIONS. THE FAT DEPT. VERIFIED THE FAILURE MESSAGE OF SOFTWARE WOULD NOT BE ABLE TO INSTALL DURING HTC EXECUTIVE PROCESSOR BOARD TESTED. ALSO, THE FAT DEPT. SAW ERROR CODE#8 WITH ALARM ON DISPLAY DURING SWEMCO POWER MANAGEMENT BOARD TESTED. BOTH PARTS FAILED TESTING. THE FOLLOWING PARTS PASSED FUNCTIONAL TESTS. ALSO, THE FAT DEPT. ABLE TO BE INSTALLED SOFTWARE. HTC EXECUTIVE PROCESSOR BOARD, NBS FRONT END BOARD, KIT, VIDEO GEN. BOARD TO DISPLAY MONITOR BOARD, NBS VIDEO GEN. BOARD (PART OF KIT), SWEMCO DISPLAY MONITOR BOARD (PART OF KIT), MWTS CABLE ASSY, (PART OF KIT). THE FAT DEPT COULD NOT VERIFY THE FAILURE MESSAGE OF SOFTWARE WOULD NOT BE ABLE TO INSTALL. RETAINING ALL PARTS IN THE FAT DEPT. DUE TO OLD PART REVISION, THE FOLLOWING FAILURE PARTS ARE NOT GOING TO SUPPLIER FOR FURTHER INVESTIGATION: SWEMCO POWER MANAGEMENT BOARD, HTC EXECUTIVE PROCESSOR BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING UNRELATED FIELD ACTIONS PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP HAD FRONT END BOARD CARD FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018600 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown