BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 22131293 · Received June 3, 2025

    Report

    Report Number
    2936999-2025-00336
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 10, 2025
    Report Date
    January 7, 2026
    Manufacturer
    JABIL CIRCUIT SINGAPORE PTE LTD
    Product Code
    OLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: PMB4000DOC, BIS ADVANCE DOCKING STATION PMB4000DOC (SERIAL# (B)(6); 186-0195-AMS, 186-0195-AMS ASPECT BIS X X1 (SERIAL # (B)(6) 186-0107, 186-0107 PIC+ X1 (LOT# GR106685) 186-0106, 186-0106 QUATRO SENSOR X25, (LOT# UNKNOWN). 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

    ADDITIONAL INFORMATION: D9, G3, H3, H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY (HIP ENDOPROTHESIS) WITH TIVA ANESTHESIA, THE CUSTOMER NOTICED A BURNT SMELL. UPON INSPECTION, FOUND THAT THE CONNECTION BETWEEN THE POWER SOURCE AND THE DOCKING STATION HAD STARTED TO MELT. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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

    CORRECTION: B5, G3, H6. 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

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY (HIP ENDOPROTHESIS) WITH TIVA ANESTHESIA, THE CUSTOMER NOTICED A BURNT SMELL. UPON INSPECTION, FOUND THAT THE CONNECTION BETWEEN THE POWER SOURCE AND THE DOCKING STATION HAD STARTED TO MELT. BEFORE ANY FIRE OCCURRED, THE MONITOR WAS IMMEDIATELY SWITCHED OFF AND DISCONNECTED FROM THE MAINS. THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY (HIP ENDOPROTHESIS) WITH TIVA ANESTHESIA, THE CUSTOMER NOTICED A BURNT SMELL. UPON INSPECTION, FOUND THAT THE CONNECTION BETWEEN THE POWER SOURCE AND THE DOCKING STATION HAD STARTED TO MELT. BEFORE ANY FIRE OCCURRED, THE MONITOR WAS IMMEDIATELY SWITCHED OFF AND DISCONNECTED FROM THE MAINS. THERE WAS NO POWER OUTAGE AT THE TIME. THE GENERAL POWER STRIP ON THE INFUSION STAND WAS USED. THE ANESTHESIA DEVICE WAS CONNECTED TO A GENERAL SOCKET IN THE OPERATING ROOM. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432643 BIS INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR OLW JABIL CIRCUIT SINGAPORE PTE LTD PMB4000CEIFU-WE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE NOTES ON H11.