BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 2001

    MDR report key: 14598200 · Received June 3, 2022

    Report

    Report Number
    2024841-2022-00001
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    April 9, 2022
    Report Date
    June 3, 2022
    Manufacturer
    PASSY-MUIR, INC.
    Product Code
    JOH
    UDI-DI
    10859760005148
    PMA / PMN Number
    K962714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT DID NOT INVOLVE MALFUNCTION OF THE PASSY-MUIR VALVE. THE USER PRACTICED OUTSIDE OF THEIR SCOPE AND FAILED TO FOLLOW MANUFACTURER'S INSTRUCTIONS STATING THAT THE 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 NOT BE ABLE 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 THE PASSY-MUIR VALVE IN PLACE.

    Description of Event or Problem · 0

    PATIENT TRANSFERRED FROM HIGHER LEVEL OF ACUTE CARE TO LOWER LEVEL. PRIOR TO TRANSFER, PATIENT USING VALVE ((B)(4)) WHEN OFF VENTILATOR. HOWEVER, AFTER TRANSFER, REPORT OF INCREASED SECRETIONS. PLACED BACK ON VENT OVERNIGHT. AT 8 AM ON (B)(6) 2022 WAS SUCTIONED AND TAKEN OFF VENT. PLACED ON TRACH COLLAR WITH CUFF LEFT INFLATED DUE TO SECRETIONS. CARE PARTNER ENTERED ROOM TO ASSIST WITH FEEDING, PLACED THE PASSY-MUIR VALVE WITHOUT ASSESSING CUFF STATUS. PATIENT EXHIBITED SIGNIFICANT DESATURATIONS AND BRADYCARDIA. MEDICAL INTERVENTION WAS REQUIRED. TEAM REMOVED VALVE AND PLACED PATIENT BACK ON VENTILATOR. HOSPITAL EVALUATED THE SITUATION AND FILED A SAFETY INTELLIGENCE REPORT WITH THE FOLLOWING FINDINGS: CARE PARTNER FROM HOME PRACTICED OUTSIDE OF SCOPE AS THEY ARE NOT ALLOWED TO PLACE SPEAKING VALVES WITHIN THE HOSPITAL SETTING; SIGNAGE RELATED TO VALVE USE AND CUFF DEFLATION DID NOT ACCOMPANY PATIENT FROM HIGHER LEVEL OF CARE; WARNING LABEL WAS NOT IN PLACE (PRIOR USAGE UNKNOWN). HOSPITAL HAS IMPLEMENTED: RT TO HAVE RESPONSIBILITY FOR SIGNAGE AND ASCERTAIN THAT IT IS POSTED IN ROOMS FOLLOWING TRANSFERS, SPEECH-LANGUAGE PATHOLOGIST TO BE CONSULTED IF A PATIENT IS ADMITTED WITH A TRACHEOSTOMY, WARNING LABELS TO BE USED ON ALL PATIENTS, SIGNAGE TO BE PLACED AT HEAD OF BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801785 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 61 YR Male Required Intervention