BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPV

    MDR report key: 19892920 · Received August 2, 2024

    Report

    Report Number
    3029845-2024-00040
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 2, 2024
    Manufacturer
    PERCUSSIONAIRE
    Product Code
    NHJ
    PMA / PMN Number
    K905236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE PATIENT EXPERIENCING A DROP IN OXYGEN SATURATION AND A TRACHEAL TEAR, THIS EVENT IS BEING REPORTED. THE DEVICE WAS NOT RETURNED FOR A FORMAL EVALUATION AND THE INFORMATION RECEIVED BY THE CUSTOMER WAS LIMITED TO WHAT WAS RECEIVED FROM THE MEDSUN REPORT. THE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE MISUSES OF THE DEVICE BY THE END USER. PER THE MEDSUN REPORT, IT WAS CONFIRMED BY THE CUSTOMER THAT A STEP OF REMOVING THE BLUE CAP WAS MISSED PRIOR TO RE-IMPLEMENTING THERAPY DIRECTLY TO THE PATIENT'S AIRWAY, RESULTING IN A TRACHEAL TEAR. AT THIS TIME, NO OTHER INFORMATION HAS BEEN RECEIVED ABOUT THIS EVENT OR THE PATIENT'S STATUS. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON JULY 3, 2024, CUSTOMER SERVICE WAS NOTIFIED BY AN SENTEC EMPLOYEE, OF AN ADVERSE EVENT THAT OCCURRED AT (B)(6). THE EMPLOYEE STATED SPEAKING WITH THE CUSTOMER, IT WAS MENTIONED THAT ABOUT A MONTH AGO A MEDICAL STUDENT WAS PROVIDING A PATIENT WITH IPV THERAPY VIA IN-LINE, AND TRANSITIONED DIRECTLY TO PATIENT'S AIRWAY WITHOUT REMOVING THE BLUE CAP FROM THE PHASITRON. THE PATIENT EXPERIENCED A TRACHEOBRONCHIAL TEAR. THE CUSTOMER STATED THAT A MEDSUN REPORT WAS SUBMITTED IN WHICH IT WAS REITERATED IN THE REPORT THAT THE PATIENT WAS GIVEN IPV TREATMENT DIRECTLY IN-LINE VIA ETT. THE PATIENT DID NOT TOLERATE IT SHORTLY AFTER INITIATION, AND EXPERIENCED DESAT. THE PATIENT WAS PLACED BACK ONTP THE VENTILATOR FOR 10 MINUTES. AN RESPIRATORY THERAPIST WORKING ALONGSIDE A STUDENT MISSED THE STEP OF REMOVING THE BLUE CAP FROM THE EXPIRATORY PORT, WHICH RESULTED IN THE PATIENT EXPERIENCING A TRACHEAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740255 IPV NONCONTINUOUS VENTILATOR NHJ PERCUSSIONAIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Life Threatening