BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPV-1C

    MDR report key: 19729132 · Received July 12, 2024

    Report

    Report Number
    3029845-2024-00039
    Event Type
    Injury
    Date Received
    July 12, 2024
    Report Date
    July 12, 2024
    Manufacturer
    PERCUSSIONAIRE
    Product Code
    NHJ
    UDI-DI
    00849436000020
    PMA / PMN Number
    K905236
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING REPORTED DUE THE PATIENT EXPERIENCING CARDIAC ARREST. LIMITED INFORMATION IS AVAILABLE ON THIS EVENT, AS THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS UPON REQUEST. IT WAS REPORTED ON JUNE 13, 2024, BY A SENTEC EMPLOYEE THAT A REPRESENTATIVE AT (B)(6) LOCATED IN (B)(6), STATED THAT A PEDIATRIC PATIENT EXPERIENCED CARDIAC ARREST DUE TO APPLICATION ERRORS WITH AN IPV-1C DEVICE. AS THE DEVICE WAS NOT RETURNED FOR A FORMAL INVESTIGATION, AND THE CUSTOMER ADVERSE EVENT FORMS WERE NOT RETURNED UPON REQUEST, NO FORMAL ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME ON THE EVENT OR PATIENT STATUS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON JUNE 13, 2024, A SENTEC EMPLOYEE WAS MADE AWARE OF AN ADVERSE EVENT WITH THE IPV-1C DEVICE OCURRING AT (B)(6). LIMITED INFORMATION IS AVAILABLE ON THIS EVENT, AS THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION ON THE EVENT WHEN REQUESTED. IT WAS RELAYED TO A SENTEC EMPLOYEE VIA PHONE CALL THAT A PEDIATRIC PATIENT EXPERIENCED CARDIAC ARREST DUE TO APPLICATION ERRORS WITH THE DEVICE. NO DATE OF WHEN THE EVENT OCCURRED WAS PROVIDED, AS WELL AS NO ADDITIONAL INFORMATION WAS PROVIDED ON PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273287 IPV-1C NONCONTINUOUS VENTILATOR NHJ PERCUSSIONAIRE F00001-C 00849436000020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening