BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTEC IPV THERAPY

    MDR report key: 19891872 · Received August 2, 2024

    Report

    Report Number
    19891872
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 16, 2024
    Manufacturer
    PERCUSSIONAIRE CORP.
    Product Code
    NHJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS GIVEN IPV TREATMENT DIRECTLY IN-LINE VIA ENDOTRACHEAL TUBE (ETT), DID NOT TOLERATE SHORTLY AFTER INITIATION. PATIENT OBSERVED TO DESAT AND WAS PROMPTLY PLACED BACK ON VENTILATOR TO RESUME TX IN-LINE VIA VENTILATOR FOR 10 MINUTES. AN RT WORKING ALONGSIDE A STUDENT, MISSED A STEP WHEN PROVING CARE (DID NOT REMOVE THE CAP OFF AN EXHALATION VALVE), WHICH RESULTED IN A TRACHEAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740175 SENTEC IPV THERAPY DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ PERCUSSIONAIRE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female