BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    560BC BIO CONSOLE

    MDR report key: 17832035 · Received September 28, 2023

    Report

    Report Number
    2184009-2023-00961
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 24, 2023
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K080824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H4. MANUFACTURING DATE 2006-12-26. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: DURING PREVENTIVE MAINTENANCE THE SERVICE TECHNICIAN OBSERVED THAT THE INSTRUMENT SHUT OFF AND WOULD NOT POWER ON AGAIN. WHILE RUNNING THE INSTRUMENT AND REMOVING EXTERNAL POWER, THE BATTERY CHARGE INDICATOR WOULD IMMEDIATELY GO FROM FULL CHARGE TO EMPTY AND THE LOW BATTERY ALARM WOULD APPEAR. THE ISSUE WAS RESOLVED BY REPLACING THE BATTERY,12V,6.5 AH ,CERTIFIED AND THE POWER SUPPLY 28V . THE POWER SUPPLY CORRECTED THE ISSUE. THE SERVICE TECHNICIAN TESTED THE INSTRUMENT BY RUNNING THE NEW BATTERIES FOR 10 MINUTES WITHOUT ISSUES. PREVENTIVE MAINTENANCE WAS COMPLETED PER SPECIFICATIONS. NOTE THAT THE INSTRUMENT WAS NOT RETURNED TO MEDTRONIC FACILITY BUT WAS SERVICED BY FIELD SERVICE TECHNICIAN. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DURING PREVENTIVE MAINTENANCE BY A SERVICE TECHNICIAN THIS BIO-CONSOLE INSTRUMENT SHUT OFF AND WOULD NOT POWER BACK ON. THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT SERVICE IS UNABLE TO CONFIRM IF ERROR WARNING APPEARED, AS THEY OBSERVED THE INSTRUMENT WAS TURNED OFF WHEN ISSUE WAS OBSERVED. THERE WAS NO DAMAGE NOTED ON THE UNIT. AFTER BATTERY REPLACEMENT, NO ABNORMALITIES WERE NOTED. THERE WAS NO VISIBLE AIR IN THE SYSTEM AND NO ABNORMAL ELECTRICAL EVENT. INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES BEFORE SHUTTING DOWN. INSTRUMENT WAS PLUGGED INTO THE EXTERNAL POWER THE ENTIRE TIME. THE INSTRUMENT COMPLETELY SHUT DOWN AND WOULD NOT POWER BACK ON, AND WAS UNABLE TO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340544 560BC BIO CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA PERFUSION SYSTEMS 560BC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown