BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONARMED

    MDR report key: 18883083 · Received March 11, 2024

    Report

    Report Number
    1282497-2024-00028
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    June 13, 2023
    Report Date
    May 8, 2024
    Manufacturer
    SONARMED, INC.
    Product Code
    OQU
    UDI-DI
    00851334007193
    PMA / PMN Number
    K193058
    Removal / Correction Number
    Z-1520-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E. MEDTRONIC PERSONNEL REPORTED THE EVENT ON BEHALF OF THE CUSTOMER. THE INVESTIGATION IS CURRENTLY IN PROGRESS. THERE IS AN EXISTING PREVIOUS INTERNAL INVESTIGATION REGARDING THE REPORTED ISSUE. 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.

    Additional Manufacturer Narrative · 0

    SECTION E FACILITY ADDED SECTION H9: 806 NUMBER 3009023584-03-08-2024-01-R SECTION H6 EVALUATION CODES UPDATED DUE TO COMPLETION OF INVESTIGATION METHOD - REMOVE B21 AND ADD B01 RESULT - REMOVE C21 AND ADD C0402 CONCLUSION - REMOVE D16 AND ADD D03 COMPONENT - REMOVE G07003 AND ADD G03012 H3 DEVICE EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED ON ALL INFORMATION RECEIVED. IT WAS REPORTED THAT, DURING TESTING, IT WAS ¿EXTREMELY¿ DIFFICULT TO PASS A SUCTION CATHETER THROUGH THIS SONARMED 3.0MM SENSOR. THERE IS A ¿PINCH¿ OF SORTS AT ABOUT THE SECOND MICROPHONE AND THE TIP THAT GOES INTO THE ENDOTRACHEAL TUBE (ETT). ONE SENSOR WAS RETURNED FOR FAILURE INVESTIGATION. VISUAL INSPECTION SHOWED THE INNER LUMEN OF THE SENSOR LUMEN TUBE IS PARTIALLY OCCLUDED. THE ANALYSIS SHOWED THE DIFFICULT PASS THROUGH BY THE SUCTION CATHETER WAS DUE TO A PARTIALLY OCCLUDED INNER LUMEN ASSOCIATED WITH THE TWEAKER SCREW FOR MICROPHONE 2 ADJUSTED TIGHTER THAN THE TWEAKER SCREW FOR MICROPHONE 1. A PIN INSERTION FORCE COULD NOT BE DETERMINED. THE CAUSE OF THE ISSUE WAS ISOLATED TO AN OBSTRUCTION IN THE SENSOR. AN EXISTING CORRECTIVE ACTION ADDRESSES THE ISSUE. I 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 TESTING, IT WAS ¿EXTREMELY¿ DIFFICULT TO PASS A SUCTION CATHETER THROUGH THIS SONARMED 3.0MM SENSOR. THERE IS A ¿PINCH¿ OF SORTS AT ABOUT THE SECOND MICROPHONE AND THE TIP THAT GOES INTO THE ENDOTRACHEAL TUBE (ETT).  THE SENSOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909531 SONARMED AIRWAY MONITORING SYSTEM OQU SONARMED, INC. AW-S030 00851334007193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown