BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 2001

    MDR report key: 11282660 · Received February 4, 2021

    Report

    Report Number
    2024841-2021-00001
    Event Type
    Injury
    Date Received
    February 4, 2021
    Report Date
    February 3, 2021
    Manufacturer
    PASSY-MUIR, INC.
    Product Code
    JOH
    UDI-DI
    10859760005148
    PMA / PMN Number
    K962714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 IN THE PATIENT CHART. THIS PRODUCT IS BRIGHTLY COLORED AND MARKED PASSY-MUIR.

    Description of Event or Problem · 1

    AS REPORTED BY DOCTOR: AT THE END OF A BRIEF PROCEDURE, A CUFFED TRACH TUBE WAS REPLACED IN THE ESTABLISHED TRACHEOTOMY TRACT AND THE PATIENT WAS VENTILATED THROUGH IT. AFTER THE PATIENT WAS BREATHING SPONTANEOUSLY, BUT BEFORE THE ABILITY TO COMMUNICATE EFFECTIVELY RETURNED, THE ASSEMBLY WHICH THE PATIENT HAD WORN INTO THE OR, CONSISTING OF THE (PURPLE) PM VALVE AND A MEANS OF DELIVERING OXYGEN, WAS REPLACED. NOBODY REALIZED THAT EITHER THE VALVE SHOULD HAVE BEEN REMOVED OR THE CUFF SHOULD HAVE BEEN DEFLATED. FAIRLY SOON, THE PATIENT'S RESPIRATORY STATUS DECLINED AND PENEUMOTHORAX WAS IDENTIFIED QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178653 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 Required Intervention