BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 007

    MDR report key: 20761751 · Received November 22, 2024

    Report

    Report Number
    2024841-2024-00001
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    August 2, 2024
    Report Date
    November 21, 2024
    Manufacturer
    PASSY-MUIR INC.
    Product Code
    JOH
    PMA / PMN Number
    K903699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT INVOLVE A MALFUNCTION OF THE PASSY-MUIR VALVE. THE USER FAILED TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS STATING THAT THE TRACHEOSTOMY CUFF MUST BE COMPLETELY DEFLATED WHEN THE PASSY-MUIR VALVE IS PLACED. AS THE MANUFACTURER OF THE PASSY-MUIR VALVE, WE TAKE SPECIAL CARE TO PACKAGE EVERY VALVE WITH A COMPREHENSIVE CLINICAL INSTRUCTION BOOKLET AND CAUTION LABELS WARNING THE USER TO COMPLETELY DEFLATE THE TRACHEOSTOMY TUBE CUFF BEFORE PLACING THE PASSY-MUIR VALVE. THE IFU AND WARNINGS STATE THAT THE PATIENT WILL BE UNABLE TO BREATHE IF THE CUFF IS NOT COMPLETELY DEFLATED. THE CAUTION LABELS ARE BRIGHTLY COLORED AND DESIGNED TO BE PLACED ON THE TRACHEOSTOMY TUBE PILOT LINE WHERE THE CUFF IS INFLATED AND DEFLATED. DISCLAIMER: SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT ANY MEDICAL PERSONNEL, USER FACILITY, DISTRIBUTOR, MANUFACTURER, OR DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE PROBLEM ARISES WHEN THE CUFF IS INADVERTENTLY INFLATED - EITHER DUE TO A LACK OF TRAINING WITH DEVICE, OR NOT REALISING IT IS IN THE CIRCUIT - AS IT IS VERY MUCH COLOURED THE SAME AS THE OTHER COMPONENTS OF THE VENTILATOR IS IN NO WAY OBVIOUS THAT IT IS THERE AND SOMEONE UNFAMILIAR MAY NOT REALISE. IN THE INCIDENT RECENTLY ON OUR UNIT THE ANAESTHETIC CONSULTANT DID NOT EVEN NOTICE AND HAD NEVER SEEN ONE BEFORE. UNFORTUNATELY, THE NURSE IN THE BED SPACE HADN'T APPRECIATE THERE WAS A "SPEAKING VALVE" IN THE CIRCUIT AS IT IS SO DISGUISED IN THE TUBING AND OFTEN THEY ASSOCIATE SPEAKING VALVE WITH SMALL WHITE AND GREEN CAPS DIRECTLY ON THE TRACHEOSTOMY IN PATIENTS BREATHING WITHOUT A VENTILATOR. OUR PATIENT WAS CONNECTED WITH THE CUFF UP SO COULD ONLY INHALE FOR ONE BREATH AT WHICH POINT HIS LUNGS WERE INFLATED AND THEREFORE COULD NOT TAKE ANOTHER BREATH. HE BECAME RAPIDLY HYPOXIC, SPEAKING VALVE WAS NOTED AND APPROPRIATE REMEDIAL ACTION WAS TAKEN. WE HAVE THEN ISSUED OUR OWN INTERNAL SAFETY NOTICE, SENT OUT TO ALL ANAESTHETISTS AND ANYONE DOING INTENSIVE CARE UNIT (ICU) TRANSFERS AND ALL ICU NURSES. OUR PROFESSIONAL DEVELOPMENT NURSES ARE ALSO ENSURING THAT ALL NURSES HAVE APPROPRIATE EDUCATION AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602156 PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 007 TRACHEOSTOMY SPEAKING VALVE JOH PASSY-MUIR INC. PMV 007 007-230429I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention