BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSY-MUIR TRACHEOSTOMY & VENT SPEAKING VALVE

    MDR report key: 2970261 · Received February 11, 2013

    Report

    Report Number
    2970261
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 8, 2013
    Manufacturer
    PASSY-MUIR, INC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS A C4 TETRAPLEGIC AND ON A VENTILATOR FROM A FALL TWO MONTHS PRIOR TO THE EVENT. ON THE DAY OF THE EVENT AT THE REQUEST OF THE FAMILY THE RESPIRATORY THERAPIST (RT) DEFLATED THE TRACHEOSTOMY CUFF AND PLACED A PASSY-MUIR TRACHEOSTOMY AND VENTILATOR SWALLOWING AND SPEAKING VALVE TO ALLOW THE PT TO MORE EASILY SPEAK TO HIS FAMILY PRIOR TO THEIR DEPARTURE TO AIRPORT. THE RT LEFT THE PT'S FROM TO ALLOW FOR PRIVATE CONVERSATION. AFTER A SHORT VISIT PT'S FAMILY LEFT. A NIGHT SHIFT CHARGE NURSE ENTERED THE PT'S ROOM AND THE PT ASKED THAT RN TO RE-INFLATE HIS TRACHEOSTOMY CUFF, WHICH WAS DONE WHILE THE PASSY-MUIR SPEAKING VALVE WAS STILL IN-LINE WITH THE VENTILATOR CIRCUIT. THE PT'S PRIMARY RN ARRIVED MOMENTS LATER AND NOTED THE PT HAD A VERY LOW BLOOD PRESSURE AND VENTILATOR ALARMING. AN ADDITIONAL NURSE ARRIVED TO HELP AS WELL. NONE OF THE THREE NURSES RECOGNIZED THE PRESENCE OF THE PASSY-MUIR SPEAKING VALVE WITHIN THE VENTILATOR CIRCUIT. THE RT WAS ALERTED, IMMEDIATELY REMOVED THE PASSY-MUIR VALVE/VENTILATOR, AND BEGAN MENTAL VENTILATION WITH AMBU BAG TO TRACH - 100% O2. UNFORTUNATELY PT HAD CARDIAC ARREST AND RESUSCITATION EFFORTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60187 PASSY-MUIR TRACHEOSTOMY & VENT SPEAKING VALVE TRACHEOSTOMY SPEAKING VALVE JOH PASSY-MUIR, INC PMV007 007-102811-D

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death SHILEY CUFFED #8 TRACHEOSTOMY TUBE| LTV VENTILATOR