BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPV 1C

    MDR report key: 19654852 · Received July 2, 2024

    Report

    Report Number
    3029845-2024-00037
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 2, 2024
    Manufacturer
    PERCUSSIONAIRE
    Product Code
    NHJ
    UDI-DI
    00849436000020
    PMA / PMN Number
    K905236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING REPORTED DUE TO THE PATIENT REQUIRING ADDITIONAL INTERVENTION POST CARDIAC ARREST, AS WELL AS EXPERIENCING A BILATERAL PNEUMOTHORAX. THE DEVICE WAS NOT SENT BACK TO SENTEC FOR PROPER EVALUATION. HOWEVER, THROUGH COMMUNICATION OF CUSTOMER SERVICE WITH A (B)(6) HOSPITAL REPRESENTATIVE, IT WAS DETERMINED THAT THE CAUSE OF THE ADVERSE EVENT WAS THE FAILURE TO REMOVE THE BLUE CAP FROM THE PHASITRON BREATHING CIRCUIT EXPIRATORY PORT WHEN PROVIDING THERAPY THROUGH THE PATIENT'S ARTIFICIAL AIRWAY. THE IPV 1C INSTRUCTIONS FOR USE PROVIDES A WARNING TO REMOVE THE BLUE CAP WHEN PROVIDING THERAPY DIRECTLY TO THE PATIENT'S MOUTH, MASK, OR ENDOTRACHEAL TUBE. THE BLUE CAP IS ONLY USED ON THE BREATHING CIRCUIT EXPIRATORY PORT WHEN THE THERAPY IS BEING GIVEN IN CONNECTION WITH AN IN-LINE VALVE. THIS EVENT IS BEING CONCLUDED AS USER-INDUCED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ON THE PATIENT AT THIS TIME. THE INSTRUCTIONS FOR USE IS CURRENTLY BEING ASSESSED FOR BLUE CAP USE CLARITY. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS EVENT, A FOLLOW-UP MDR WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CUSTOMER SERVICE WAS NOTIFIED OF AN ADVERSE EVENT THAT OCCURRED AT (B)(6) HOSPITAL. ON (B)(6) 2024, A RESPIRATORY THERAPIST WAS PROVIDING IPV THERAPY TO A PATIENT VIA IN-LINE CONNECTION ON A MECHANICAL VENTILATOR WITH AN IPV 1C DEVICE AND DID NOT SEE THE NORMAL CHEST WIGGLE EXPECTED ON THE PATIENT. IT WAS STATED THE BLUE CAP WAS PRESENT ON THE EXPIRATORY PORT OF THE PHASITRON BREATHING CIRCUIT AT THIS TIME. THE RESPIRATORY THERAPIST DECIDED TO PERFORM THE THERAPY DIRECTLY THROUGH THE PATIENT'S ARTIFICIAL AIRWAY AND DID NOT REMOVE THE BLUE CAP FROM THE PHASITRON CIRCUIT. IT WAS REPORTED THAT AFTER ABOUT 5 SECONDS OF CONNECTION, THE PATIENT IMMEDIATELY STARTED THRASHING AND VOMITED. THE PATIENT WAS REMOVED FROM THE THERAPY AND PLACED BACK ON THE VENTILATOR. THE PATIENT WENT INTO CARDIAC ARREST AND REQUIRED CHEST COMPRESSIONS TO RETURN TO A STABLE STATE. IT WAS LATER FOUND THROUGH A CHEST X-RAY THAT THE PATIENT DEVELOPED A BILATERAL PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757459 IPV 1C NONCONTINUOUS VENTILATOR NHJ PERCUSSIONAIRE F00001-C 00849436000020

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Life Threatening