BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR LOW-PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE

    MDR report key: 7143889 · Received December 22, 2017

    Report

    Report Number
    2024841-2017-00001
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 27, 2017
    Manufacturer
    PASSY-MUIR INC.
    Product Code
    JOH
    UDI-DI
    10859760005148
    PMA / PMN Number
    K962714
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT DID NOT INVOLVE A MALFUNCTION OF THE PASSY-MUIR VALVE. THIS EVENT WAS CAUSED BY A SERIES OF USE ERRORS. THE USER DID NOT RESPOND APPROPRIATELY TO THE VENTILATOR DISCONNECT ALARM. 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. THE CUFF WAS NOT DEFLATED UNTIL THE RT RESPONDED TO THE EVENT. THE USER FAILED TO POST THE WARNING LABELS (PACKAGED WITH EACH PASSY-MUIR VALVE) ON THE TRACHEOSTOMY TUBE CUFF PILOT LINE, OR ANYWHERE WITHIN THE PROXIMITY OF THE PATIENT. AS THE MANUFACTURER OF THE PASSY-MUIR VALVE, WE TAKE SPECIAL CARE TO PACKAGE EVERY VALVE WITH A COMPREHENSIVE CLINICAL INSTRUCTION BOOKLET, PATIENT HANDBOOK, AND CAUTION LABELS. THE CAUTION LABELS ARE BRIGHTLY COLORED AND DESIGNED TO BE PLACED ON THE TRACHEOSTOMY TUBE PILOT LINE WHERE THE CUFF IS INFLATED AND DEFLATED AS WELL AS AT THE BEDSIDE AND PATIENT CHART.

    Description of Event or Problem · 1

    USER FACILITY REPORTED: RN STATES VENT WAS ALARMING. UPON ENTERING THE ROOM, THE VENTILATOR CIRCUIT WAS DISCONNECTED. RN STATES THAT THE PATIENT WAS ASKING FOR THE PASSY MUIR VALVE TO BE PLACED ON; HOWEVER, AFTER INVESTIGATION THE PATIENT WAS TELLING THE RN THAT THE VENT HAD BECOME DISCONNECTED. RN STATES THAT SHE PLACED THE PASSY MUIR VALVE ON, (WHEN ASKED IF SHE DEFLATED THE TRACH CUFF, SHE STATED NO), RN STATES THAT VENT CONTINUED TO ALARM. SHE FOUND CHARGE RN AND INFORMED HER OF THE PATIENT WITH DIFFICULTY BREATHING. THE PATIENT WAS UNRESPONSIVE, PULSELESS AND BLUE. THE RN INITIATED CHEST COMPRESSIONS AND A CODE BLUE WAS CALLED. PATIENT BECAME RESPONSIVE SHORTLY THEREAFTER. RESPIRATORY FOUND THAT THE TRACH CUFF WAS STILL INFLATED. THE RT REMOVED 10ML SYRINGE FROM WITHIN BAG HANGING FROM COUGH ASSIST MACHINE. THE PATIENT WAS SUCTIONED AND PLACED ON HUMIDIFIED TRACH COLLAR (HTC) 90%, PATIENT ABLE TO VOCALIZE WITH PASSY MUIR VALVE. DOCTOR STATES PATIENT HAD EKG CHANGES, PATIENT WAS TRANSPORTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923326 PASSY-MUIR LOW-PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE TRACHEOSTOMY SPEAKING VALVE JOH PASSY-MUIR INC. PMV 2001 001-061603D 10859760005148

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R