BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 19660370 · Received July 2, 2024

    Report

    Report Number
    3000219639-2024-00054
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 17, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    00607411952753
    PMA / PMN Number
    K984528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 02 JULY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT REPORTED "FREQUENTLY RECEIVE ALARMS FOR ELEVATED CUFF PRESSURE OR LEAKAGE. OUR PROBLEM IS LEAKAGE PAST THE CUFF AT RELATIVELY HIGH VENTILATOR PRESSURES. EXPERIENCE LEAKAGE PAST THE CUFF WITH PARKER TUBES DUE TO THE ELONGATED CUFF WHEN THE TUBE IS SOMEWHAT SMALL RELATIVE TO THE TRACHEAL SIZE." THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE COMPLAINT REPORT NO PATIENT WAS AFFECTED. THERE WERE NO PHOTO IMAGES OR VIDEOS OF THE REPORTED ISSUE; THEREFORE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THIS IS THE THIRD (3) COMPLAINT REPORTED FOR PART NUMBER I-PFHV-70-10 FOR LEAKING DURING THIS TIMEFRAME. THIS IS THE SECOND (2) COMPLAINT REPORTED FOR PART NUMBER I-PFHV-80-10 FOR LEAKING DURING THIS TIMEFRAME. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 02 JULY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    FREQUENTLY RECEIVE ALARMS FOR ELEVATED CUFF PRESSURE OR LEAKAGE. OUR PROBLEM IS LEAKAGE PAST THE CUFF AT RELATIVELY HIGH VENTILATOR PRESSURES. EXPERIENCE LEAKAGE PAST THE CUFF WITH PARKER TUBES DUE TO THE ELONGATED CUFF WHEN THE TUBE IS SOMEWHAT SMALL RELATIVE TO THE TRACHEAL SIZE.

    Description of Event or Problem · 0

    FREQUENTLY RECEIVE ALARMS FOR ELEVATED CUFF PRESSURE OR LEAKAGE. OUR PROBLEM IS LEAKAGE PAST THE CUFF AT RELATIVELY HIGH VENTILATOR PRESSURES. EXPERIENCE LEAKAGE PAST THE CUFF WITH PARKER TUBES DUE TO THE ELONGATED CUFF WHEN THE TUBE IS SOMEWHAT SMALL RELATIVE TO THE TRACHEAL SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799974 PARKER ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 8.0MM, 7.0MM BTR PARKER MEDICAL I-PFHV-70-10,I-PFHV-80-10 UNKNOWN 00607411952753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other