BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONARMED

    MDR report key: 18883060 · Received March 11, 2024

    Report

    Report Number
    1282497-2024-00026
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    December 7, 2022
    Report Date
    May 7, 2024
    Manufacturer
    SONARMED, INC.
    Product Code
    OQU
    PMA / PMN Number
    K193058
    Removal / Correction Number
    Z-1519-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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, WHILE IN USE ON A PATIENT, THE RESPIRATORY THERAPIST (RT) HAD AN ISSUE WITH PASSING A 6FRENCH CATHETER THROUGH THIS SONARMED SENSOR SINCE THE SENSOR HAD AN OBSTRUCTION. WITH MANIPULATION OF THE CATHETER THE RT WAS ABLE TO PASS THE SUCTION CATHETER INTO THE TUBE. . RT CHANGED TO A NEW 2.5 SENSOR WHICH WAS ABLE TO PASS A SUCTION CATHETER WITHOUT ANY ISSUES. THE MEDTRONIC PERSONNEL INSPECTED THE SENSOR AND CONFIRMED THE REPORTED ISSUE. THE MEDTRONIC PERSONNEL INSPECTED THE SENSOR AND FOUND THE PIECE OF PLASTIC STICKING INTO THE LUMEN, POSSIBLY FROM THE MOLDING PROCESS. THE CAUSE OF THE ISSUE WAS ISOLATED TO AN OBSTRUCTION IN THE SENSOR. AN EXISTING CORRECTIVE ACTION ADDRESSES THE ISSUE. 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, WHILE IN USE ON A PATIENT, THE RESPIRATORY THERAPIST (RT) HAD AN ISSUE WITH PASSING A 6FRENCH CATHETER THROUGH THIS SONARMED SENSOR SINCE THE SENSOR HAD AN OBSTRUCTION. WITH MANIPULATION OF THE CATHETER THE RT WAS ABLE TO PASS THE SUCTION CATHETER INTO THE TUBE. THERE WAS NO HARM CAUSED TO THE PATIENT. RT CHANGED TO A NEW 2.5 SENSOR WHICH WAS ABLE TO PASS A SUCTION CATHETER WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385155 SONARMED AIRWAY MONITORING SYSTEM OQU SONARMED, INC. AW-S025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown