BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 14408722 · Received May 16, 2022

    Report

    Report Number
    2936999-2022-00421
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    March 23, 2021
    Report Date
    June 24, 2022
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GXY
    UDI-DI
    20884521134307
    PMA / PMN Number
    K093183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING INTERVENTION, THE MONITOR DISPLAYED WRONG MEASUREMENT. THE SENSOR SHOWED A FLAT CURVE (EEG) WHICH DID NOT CORRELATE WITH THE GIVEN VALUE OF 90, WHICH MEANS THAT THE PATIENT WAS AWAKE. THE PATIENT WAS GIVEN ADDITIONAL HYPNOTICS, BUT THE VALUES DID NOT CHANGE. AFTER CHANGING THE SENSOR, THE VALUE DROPPED TO 6, WHICH MEANS THAT THE PATIENT WAS IN DEEP SLEEP.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING INTERVENTION, THE MONITOR DISPLAYED WRONG MEASUREMENT. THE SENSOR SHOWED A FLAT CURVE (EEG) WHICH DID NOT CORRELATE WITH THE GIVEN VALUE OF 90 WHICH MEANS THAT THE PATIENT WAS AWAKE. THE PATIENT WAS GIVEN ADDITIONAL HYPNOTICS, BUT THE VALUES DID NOT CHANGE. AFTER CHANGING THE SENSOR, THE VALUE DROPPED TO 6 WHICH MEANS THAT THE PATIENT WAS IN DEEP SLEEP. THE PATIENT WAS NOT INJURED BECAUSE OF THE ADDITIONAL HYPNOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092760 BIS ELECTRODE, CUTANEOUS GXY CELESTICA ELECTRONICS S PTE LTD 186-0106 1209201L 20884521134307

    Patients

    Seq Age Sex Outcome Treatment
    1 Female