BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 17692862 · Received September 6, 2023

    Report

    Report Number
    2249723-2023-03947
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 28, 2023
    Report Date
    December 5, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9(DEVICE AVAILABLE FOR EVA & RETURN TO MANUFACTURE DATE), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10, H11. ADDITIONAL INFORMATION: TEL - (B)(6). IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN WHILE ON PATIENT. GETINGE FIELD SERVICE ENGINEER (FSE) SURFACING THE CRITICAL ALARM BUZZER. USERS SWAPPED OUT THE CONSOLE TO CONTINUE TREATMENT WITHOUT ISSUE. CODE 118, VIDEO GENERATOR BOARD WATCHDOG, LOGGED FOR THAT DATE, POINTING TO THE VIDEO GENERATOR BOARD, AS OF (B)(6) 2022, ON BACK ORDER. UNIT FULLY FUNCTIONAL WHEN INITIALLY TESTED WITH TRAINER AND TESTING CATHETER. NARROWED DOWN ISSUE TO THE VIDEO GENERATOR BOARD. ON (B)(6) 2022, REPLACED VIDEO GENERATOR BOARD KIT. REPLACED EXECUTIVE PROCESSOR BOARD AT THE 8 YEAR INTERVAL. POST REPLACEMENT, SUCCESSFULLY COMPLETED A SIMULATED TREATMENT WITHOUT ISSUE. NOTEWORTHY, INADVERTENTLY CLEARED LOGS FROM THE FAULT TABLE BEFORE PRINTING AND TAKING PICTURES. PRINT STRIPS INCLUDED WITH VIDEO GENERATOR BOARD KIT, TO BE RETURNED FOR INVESTIGATION. NO PATIENT HARM. THE NATIONAL REPAIR CENTER INSTALLED THE VIDEO GENERATOR BOARD PN 0670-00-1182 ALONG WITH UPPER DISPLAY MONITOR BOARD PN 0670-00-1183 INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE BOARDS TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION C AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION P. NOT CONFIRMED WAS CHOSEN FOR PN 0670-00-1182 SN (B)(6) AND PN 0670-00-1183 SN 18 00020 51_EDM BECAUSE NRC COULD NOT CONFIRM THE FAILURE. THE NRC COULD NOT VERIFY THE FAILURE OF CODE 118 "WATCHDOG". THE VIDEO GENERATOR BOARD AND UPPER DISPLAY MONITOR BOARD PASSED TESTING. SENDING THE VIDEO GENERATOR BOARD AND UPPER DISPLAY MONITOR BOARD TO THE SUPPLIER PER PROCEDURE NUMBER 0002-07-D008 REV. AJ. RECEIVED EXECUTIVE PROCESSOR BOARD PN 0670-00-0770 FROM FIELD TECHNICIAN. THIS BOARD WAS SENT BACK BY THE FIELD REP TO HAVE THE REAL TIME CLOCK CHIP REPLACE AT THE 8 YEARS INTERVAL TO THE FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION C AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION P. THIS EXECUTIVE PROCESSOR BOARD PN 0670-00-0770 WAS SENT BACK BECAUSE OF DUE TO WATCHDOG TIMER CHIP OLDER THAN 8 YEARS. EVERY 8 YEARS THE WATCHDOG TIMER CHIP IS CHANGED DUE TO OUR PREVENTIVE MAINTENANCE SCHEDULE. PROBABLY CAUSE OF CODE 118 WAS THE OLD WATCHDOG TIMER IC. ROOT CAUSE GRID - ROOT CAUSE DETERMINED, EXPECTED WEAR AND TEAR. RETAINING THIS BOARD IN NRC PER PROCEDURE NUMBER 0002-07-D008 REV. AJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PN 0670-00-1183 SN (B)(6) BACK FROM THE SUPPLIER. RESULTS FROM THE SUPPLIER'S FAILURE ANALYSIS INDICATE THAT NO ABNORMALITIES WERE FOUND AND THE BOARD PASSES ALL FUNCTIONAL TESTS. PLEASE SEE ATTACHMENT. RETAINING THE BOARD IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AP. FAT RECEIVED PN 0670-00-1182 BACK FROM THE SUPPLIER. THE SUPPLIER STATED THEY REPLACED COMPONENTS U41 AND REWORKED J3 AND J4. NO SPECIFIC ROOT CAUSE IDENTIFIED. THIS INVESTIGATION IS NOW COMPLETE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN AIR FLOW ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858589 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.