BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSY-MUIR

    MDR report key: 7024164 · Received November 13, 2017

    Report

    Report Number
    7024164
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 9, 2017
    Manufacturer
    PASSY-MUIR, INC.
    Product Code
    JOH
    UDI-DI
    10859760005148
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN STATES VENT WAS ALARMING. UPON ENTERING THE ROOM, THE VENTILATOR CIRCUIT WAS DISCONNECTED. RN STATES THAT THE PATIENT WAS ASKING FOR THE PASSY MUIR VALVE TO BE PLACED ON; HOWEVER, AFTER INVESTIGATION THE PATIENT WAS TELLING THE RN THAT THE VENT HAD BECOME DISCONNECTED. RN STATES THAT SHE PLACED THE PASSY MUIR VALVE ON, (WHEN ASKED IF SHE DEFLATED THE TRACH CUFF, SHE STATED NO), RN STATES THAT VENT CONTINUED TO ALARM. SHE FOUND CHARGE RN AND INFORMED HER OF THE PATIENT WITH DIFFICULTY BREATHING. THE PATIENT WAS UNRESPONSIVE, PULSELESS AND BLUE. THE RN INITIATED CHEST COMPRESSIONS AND A CODE BLUE WAS CALLED. PATIENT BECAME RESPONSIVE SHORTLY THEREAFTER. RESPIRATORY FOUND THAT THE TRACH CUFF WAS STILL INFLATED. THE RT REMOVED 10ML SYRINGE FROM WITHIN BAG HANGING FROM COUGH ASSIST MACHINE. THE PATIENT WAS SUCTIONED AND PLACED ON HUMIDIFIED TRACH COLLAR (HTC) 90%, PATIENT ABLE TO VOCALIZE WITH PASSY MUIR VALVE. DOCTOR STATES PATIENT HAD EKG CHANGES, PATIENT WAS TRANSPORTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803431 PASSY-MUIR TUBE TRACHEOSTOMY AND TUBE CUFF JOH PASSY-MUIR, INC. PMV 2001 10859760005148

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R PORTEX #8 TRACHEOSTOMY WAS BEING USED AND THE CUFF