BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASITRON BREATHING CIRCUIT

    MDR report key: 21491428 · Received February 28, 2025

    Report

    Report Number
    3029845-2025-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 28, 2025
    Manufacturer
    PERCUSSIONAIRE CORP.
    Product Code
    CBK
    PMA / PMN Number
    K905235
    Removal / Correction Number
    1000524541-12/12/2024-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED DUE TO THE PHASITRON BREATHING CIRCUIT FAILING WHILE IN USE ON A VENTILATED PATIENT. THE PATIENT REQUIRED MANUAL VENTILATION, WHICH WAS AN UNANTICIPATED MEDICAL INTERVENTION, UNTIL ANOTHER BREATHING CIRCUIT WAS AVAILABLE FOR USE. NO PATIENT HARM OR INJURY WAS REPORTED. THE PRODUCT WAS RETURNED FOR INTERNAL EVALUATION AND IT WAS CONCLUDED THAT THE DEVICE FAILURE IS RELATED TO THE ONGOING FIELD SAFETY CORRECTIVE ACTION (1000524541-12/12/2024-003-C) REPORTED TO FDA ON DECEMBER 12, 2024. AS STATED IN THE REPORTED ROOT CAUSE, THIS IS IN RELATION TO THE INTERNAL VENTURI COMPONENT GETTING STUCK TO THE INTERNAL DIAMETER OF THE PHASITRON BODY. THIS IS DUE TO INACCURATE DESIGN DIMENSIONS OF THE VENTURI. PERCUSSIONAIRE HAS IMPLEMENTED 100% INCOMING INSPECTION OF THE VENTURI AND PHASITRON BODY. THE PHASITRON ALSO UNDERGOES A FUNCTIONAL EVALUATION FOR VENTURI OSCILLATION PRIOR TO FINAL MANUFACTURING RELEASE. THIS IS THE SECOND CUSTOMER REPORTED COMPLAINT RELATED TO THIS ISSUE. TH FSCA IS CURRENTLY ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS COMMUNICATED ON (B)(6) 2025, THAT WHILE A PHASITRON BREATHING CIRCUIT WAS IN USE ON A VENTILATED PATIENT, THE BREATHING CIRCUIT MALFUNCTIONED, AND WOULD NOT OSCILLATE. THE PATIENT WAS TAKEN OFF OF THE PHASITRON BREATHING CIRCUIT AND MANUALLY VENTILATED UNTIL A NEW CIRCUIT WAS AVAILABLE. A NEW CIRCUIT WAS PLACED BACK ON THE PATIENT AND CONFIRMED TO BE WORKING. NO PATIENT HARM OR INJURY WAS STATED TO HAVE OCCURRED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648825 PHASITRON BREATHING CIRCUIT PHASITRON KIT CBK PERCUSSIONAIRE CORP. A50094-D WO08063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown