BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSY-MUIR SPEAKING VALVE

    MDR report key: 2594024 · Received May 24, 2012

    Report

    Report Number
    2024841-2012-00001
    Event Type
    Death
    Date Received
    May 24, 2012
    Date of Event
    April 1, 2012
    Report Date
    April 30, 2012
    Manufacturer
    PASSY-MUIR, INC.
    Product Code
    JOH
    PMA / PMN Number
    K903699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT PROBLEM REPORTED. BASED ON THE INFORMATION REPORTED BY THE USER FACILITY IN THIS CASE, THERE WAS NO DEVICE MALFUNCTION ON THE PART OF THE PASSY-MUIR SPEAKING VALVE. THE ADVERSE EVENT OCCURRED DUE TO USER ERROR. 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. OUR PRODUCT IS NOT INTENDED TO BE ALTERED PRIOR TO USE AS HAD OCCURRED IN THIS CASE BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIAGNOSED WITH OBSTRUCTIVE SLEEP APNEA (OSA), POST RESPIRATORY FAILURE AND MORBIDLY OBESE HAD A PASSY-MUIR VALVE. THE MANAGER OF THE RESPIRATORY THERAPY DEPARTMENT AT THE HOSPITAL STATED THAT THE PASSY-MUIR VALVE WAS COVERED WITH THE END OF A GLOVE FINGER IN AN ATTEMPT TO OCCLUDE THE ONE-WAY VALVE. THE STATED LOGIC WAS TO USE IT AS A CAP FOR THE TRACHEOSTOMY TUBE. THE MODIFIED PASSY-MUIR VALVE WAS IN PLACE FOR APPROXIMATELY 12 HOURS. THE PATIENT SUFFERED RESPIRATORY ARREST SECONDARY TO A MUCOUS PLUG. THIS INCIDENT WAS NOT A RESULT OF A DEFECTIVE PRODUCT. IT WAS A RESULT OF INCORRECT USE. NO OTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSY-MUIR SPEAKING VALVE JOH PASSY-MUIR, INC. PMV 007

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SHILEY SIZE 6 XLT TRACHEOSTOMY TUBE