BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 2001

    MDR report key: 16765931 · Received April 18, 2023

    Report

    Report Number
    2024841-2023-00001
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    February 8, 2023
    Report Date
    April 18, 2023
    Manufacturer
    PASSY-MUIR INC.
    Product Code
    JOH
    UDI-DI
    10859760005148
    PMA / PMN Number
    K962714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT DID NOT INVOLVE MALFUNCTION OF THE PASSY-MUIR VALVE. THE USER FAILED TO FOLLOW MANUFACTURER'S INSTRUCTIONS STATING THAT THE TRACHEOSTOMY CUFF MUST BE COMPLETELY DEFLATED WHEN THE PASSY-MUIR VALVE IS PLACED. THE USER APPEARS TO HAVE APPLIED A MEDICAL DEVICE WITHOUT SUFFICIENT KNOWLEDGE OR UNDERSTANDING OF THE MEDICAL DEVICE. 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 THAT WARN "TRACHEOSTOMY TUBE CUFF MUST BE COMPLETELY DEFLATED BEFORE PLACING THE PMV" AND THAT "THE PATIENT WILL BE UNABLE TO BREATHE IF CUFF IS NOT COMPLETELY DEFLATED". THE CAUTION LABELS ARE DESIGNED TO BE PLACED ON THE TRACHEOSTOMY TUBE PILOT LINE WHERE THE CUFF IS INFLATED AND DEFLATED, AS WELL AS AT THE BEDSIDE AND IN THE PATIENT CHART. THE CAUTION LABELS ARE BRIGHTLY COLORED TO BRING ATTENTION TO THE CAUTION OF CUFF DEFLATION AND ENSURE PROPER PATIENT MONITORING WITH PASSY-MUIR VALVE IN PLACE. 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

    PATIENT HAD TRACHEOSTOMY AND HAD CUFF INFLATED DURING PROCEDURE IN OR. THE PATIENT WAS TRANSFERRED TO AN ICU POST-OPERATIVELY. THE CUFF WAS STILL INFLATED. THE NURSE CARING FOR THE PATIENT ATTACHED THE PASSY-MUIR VALVE TO THE TRACH WHILE THE CUFF WAS INFLATED TO ALLOW THE PATIENT TO SPEAK. THE PATIENT BECAME BRADYCARDIAC, DESATURATED EVENTUALLY PEA ARRESTED. A CODE WAS CALLED, AND IT WAS REALIZED DURING THE CODE THE CUFF WAS INFLATED AND ATTACHED. THE VALVE WAS REMOVED ALLOWING FOR AN UNOBSTRUCTED AIRWAY, AND THE PATIENT RESUSCITATED. THE PATIENT REMAINS IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186892 PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 2001 TRACHEOSTOMY SPEAKING VALVE JOH PASSY-MUIR INC. PMV 2001 UNKNOWN 10859760005148

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| L| H