BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 007

    MDR report key: 8819487 · Received July 23, 2019

    Report

    Report Number
    2024841-2019-00004
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    May 4, 2019
    Report Date
    July 23, 2019
    Manufacturer
    PASSY-MUIR INC.
    Product Code
    JOH
    UDI-DI
    10859760005025
    PMA / PMN Number
    K903699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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. 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. 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. ON (B)(6) 2019, THE DATE OF EVENT ((B)(6) 2019) WAS OBTAINED BY PASSY-MUIR FROM THE USER FACILITY. - ATTACHMENT: [SUBMITTAL COVER LETTER MDR 2024841-2019-00004.PDF].

    Description of Event or Problem · 0

    NON-FATALITY REPORT: USER FACILITY COMBINED FOUR INCIDENTS TOGETHER WITH THE SAME NARRATIVE. THE MANUFACTURER IS REQUIRED TO FILE FOUR SEPARATE REPORTS (MFR REPORT #2024841-2019-00001, 2024841-2019-00002, 2024841-2019-00003, AND 2024841-2019-00004) IN RESPONSE TO THE COMBINED NARRATIVE. USER FACILITY REPORTED: "4 X SEPARATE INCIDENTS IN CRITICAL CARE OVER 6-8 MONTH PERIOD WHERE TRACHEOSTOMY CUFF INFLATION WHILE PMV IN SITU IN VENTILATOR DEPENDENT PATIENTS HAS LEAD TO PATIENT DETERIORATION AND PERI-ARREST INCIDENT BEFORE THIS ERROR HAS BEEN RECOGNISED. PATIENT REQUIRED MANUAL BAG VENTILATION AND/OR PERI ARREST MANAGEMENT TO PREVENT CARDIAC ARREST AND/OR DEATH. ALL PATIENTS RECOVERED FULLY. ALL INCIDENTS INVESTIGATED.".

    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. 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. THE CAUTION LABELS ARE BRIGHTLY COLORED AND DESIGNED TO BE PLACED ON THE TRACHEOSTOMY TUBE PILOT LINE WHERE THE CUFF IS INFLATED AND DEFLATED.

    Description of Event or Problem · 1

    NON-FATALITY REPORT: USER FACILITY COMBINED FOUR INCIDENTS TOGETHER WITH THE SAME NARRATIVE. THE MANUFACTURER IS REQUIRED TO FILE FOUR SEPARATE REPORTS (MFR REPORT #2024841-2019-00001, 2024841-2019-00002, 2024841-2019-00003, AND 2024841-2019-00004) IN RESPONSE TO THE COMBINED NARRATIVE. USER FACILITY REPORTED: "4 X SEPARATE INCIDENTS IN CRITICAL CARE OVER 6-8 MONTH PERIOD WHERE TRACHEOSTOMY CUFF INFLATION WHILE PMV IN SITU IN VENTILATOR DEPENDENT PATIENTS HAS LEAD TO PATIENT DETERIORATION AND PERI-ARREST INCIDENT BEFORE THIS ERROR HAS BEEN RECOGNISED. PATIENT REQUIRED MANUAL BAG VENTILATION AND/OR PERI ARREST MANAGEMENT TO PREVENT CARDIAC ARREST AND/OR DEATH. ALL PATIENTS RECOVERED FULLY. ALL INCIDENTS INVESTIGATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609370 PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 007 PASSY-MUIR VALVE JOH PASSY-MUIR INC. PMV 007 UNKNOWN 10859760005025

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening