BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO CONSOLE 560

    MDR report key: 23743991 · Received December 8, 2025

    Report

    Report Number
    2184009-2025-01595
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 16, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWA
    UDI-DI
    00763000236526
    PMA / PMN Number
    K080824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BATTERY FAILURE WAS VERIFIED BY THE CUSTOMER AND THE SERVICE TEAM THROUGH TESTING. THE BATTERIES WERE INSTALLED IN 2022 AND ITS ORIGINAL LOT NUMBER IS 2223/ 190222-M. DEVICE EVALUATION SUMMARY: THE REPORTED BATTERY FAILURE WAS VERIFIED DURING SERVICE. THE ISSUE WAS RESOLVED BY REPLACING THE BATTERY,12V,6.5 AH,CERTIFIED *2 AND ADJUSTING THE POWER SUPPLY VOLTAGE FROM 29.91VDC TO 30VDC AS A PRECAUTION. PREVENTATIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. NOTE: THE INSTRUMENT WAS SERVICED IN THE FACILITY BY A FIELD SERVICE TECHNICIAN. THE INSTRUMENT WAS NOT RETURNED TO A MEDTRONIC FACILITY FOR SERVICE/ANALYSIS. H.6: ANNEX B, ANNEX C AND ANNEX D CODES UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-CONSOLE 560 INSTRUMENT, IT WAS REPORTED A BATTERY FAILURE. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455187 BIO CONSOLE 560 CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA PERFUSION SYSTEMS 560BCS1 00763000236526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown