BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 18630494 · Received February 2, 2024

    Report

    Report Number
    2936999-2024-00210
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    October 1, 2021
    Report Date
    February 2, 2024
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 186-0160 - 186-0160 SENSOR BIS EXTEND X25, LOT# 0611211L THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER CRP NO. 1000199834/NC36. 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, THE SENSOR WERE USED WITH THE MODULES AND STAND ALONE MONITORS AND THE SENSORS FAILED ON ALL OF THEM. THE READING WAS TOO LOW AND THE CUSTOMER SAID THAT THERE WERE NOT EVEN ON THE FOREHEAD PROPERLY AND STARTED READING A BIS OF BELOW 30. WHEN IT WERE IN THE CORRECT PLACE, THE READING WAS BELOW 30 EVEN THOUGH THE PATIENT WERE VERY LIGHTY SEDATED. THERE WAS NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572461 BIS ELECTRODE, CUTANEOUS GXY CELESTICA ELECTRONICS S PTE LTD 186-0106 1111201L 20884521134307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10