BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 18717142 · Received February 15, 2024

    Report

    Report Number
    2249723-2024-00688
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    February 1, 2024
    Report Date
    November 14, 2024
    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
    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) INVESTIGATED THE CUSTOMER'S COMPLAINT CONFIRMED SCREEN DEFECT OCCURRED. IT IS STILL UNDER MANUFACTURER'S WARRANTY. REPLACED THE VIDEO GENERATOR BOARD (040-00-0456). OPERATION CHECK COMPLETED. THE FOLLOWING WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0040-00-0456, SN: N/A KIT, DISPLAY MONITOR TO VIDEO GEN BOARD. PN: 0670-00-1182, SN: (B)(6)_SPV VIDEO GEN BOARD (PART OF KIT). PN: 0670-00-1183, SN: (B)(6)_EDM DISPLAY MONITOR BOARD (PART OF KIT). PN: 0012-00-1845, SN: (B)(6)_MWTS CABLE ASSY. (PART OF KIT). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF SCREEN MALFUNCTION OCCURRED. PERFORMED VISUAL INSPECTION OF THESE ALL PARTS RECEIVED AND ALL PARTS LOOKS TO BE IN GOOD CONDITION. INSTALLED KIT, DISPLAY MONITOR TO VIDEO GEN BOARD INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TOGETHER AND SEPARATELY TO THE FACTORY SPECIFICATIONS AND THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF SCREEN MALFUNCTION. KIT, DISPLAY MONITOR TO VIDEO GEN BOARD WORKED CORRECTLY AND ALL PARTS OF KIT PASSED TESTING. SENT FOLLOWING TO THE SUPPLIER FOR FURTHER INVESTIGATION PER PROCEDURE 0002-07-D008 REV AQ. PN: 0670-00-1182, SN: (B)(6)_SPV VIDEO GEN BOARD (PART OF KIT). PN: 0670-00-1183, SN: (B)(6)_EDM DISPLAY MONITOR BOARD (PART OF KIT). RETAINING PN: 0012-00-1845, SN: (B)(6)_MWTS CABLE ASSY. (PART OF KIT) IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AQ. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAT DEPT. RECEIVED PART NUMBER 0670-00-1183 REV C, DISPLAY MONITOR BOARD SERIAL NUMBER (B)(6)_EDM 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 FOLLOWING WAS SUBMITTED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN 0670-00-1182. THEY STATED THAT THE PART FAILED THE FCT TEST AND U41 COMPONENT IS FAULT. PROBABLE ROOT CAUSE IS A DESIGN ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ISSUE OCCUR WHERE THE SCREEN DISPLAY FLICKERED OR BECAME BLURRY. NO PATIENT INJURY OR HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747073 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