BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 22131312 · Received June 3, 2025

    Report

    Report Number
    2936999-2025-00337
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 10, 2025
    Report Date
    January 20, 2026
    Manufacturer
    JABIL CIRCUIT SINGAPORE PTE LTD
    Product Code
    OLW
    UDI-DI
    10884521808300
    PMA / PMN Number
    EXEMPTED
    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: PMB4000CEIFU-WE, PMB4000CEIFU-WE BIS MON-IFU W EUROPE (SERIAL# J(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, H6. H3 EVALUATION SUMMARY MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED POWER SUPPLY CONNECTOR STUCK INSIDE OF THE DOCKING STATION CHARGING PORT DUE TO THE CONNECTOR HOUSING MELTING. WHEN EXAMINING THE OUTER SURFACE OF THE DOCKING STATION, THERMAL DAMAGE WAS OBSERVED. FUNCTIONALLY, CHARRING AND THERMAL DAMAGE WAS OBSERVED ON MULTIPLE COMPONENTS NEAR THE CHARGING PORT ON THE BOARD (PCBA). THE AREA OF THE PCBA NEAR THE VENT OF THE HOUSING APPEARED TO CONTAIN AN INGRESS STAIN. THE POWER CORD WAS EXAMINED AND THERE WERE NO SIGNS OF EXPOSED COPPER WIRES. THE BACK METAL PLATE INSIDE OF THE DOCKING STATION CONTAINED SIGNS OF CORROSION ALONG THE TOP EDGE, HOWEVER THERE WAS NO OBVIOUS SIGNS OF THERMAL DAMAGE NEAR THE PLATE. THE TABLET WAS CONNECTED TO AC POWER USING A KNOWN GOOD POWER SUPPLY AND THE SYSTEM POWER ON AND COMPLETED POST (POWER ON SELF TEST) WITHOUT GENERATING ANY ERRORS. WHEN EXAMINING THE TABLET THERE WERE NO SIGNS OF PHYSICAL OR THERMAL DAMAGE. THE TABLET WAS NOT AFFECTED BY THE DOCKING STATION THAT WAS USED AT THE TIME OF THE EVENT. 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 REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO COMPONENT FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGERY (HIP ENDOPROSTHESIS) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396710 BIS INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR OLW JABIL CIRCUIT SINGAPORE PTE LTD PMB4000DOC 10884521808300

    Patients

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