BEUDAMED
    FDA Adverse Event Death Summary report: N

    L FITLIFE MASK EE W/HGR JPN

    MDR report key: 7130788 · Received December 19, 2017

    Report

    Report Number
    2518422-2017-02933
    Event Type
    Death
    Date Received
    December 19, 2017
    Date of Event
    December 11, 2017
    Report Date
    January 22, 2018
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K072592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS INFORMED THAT THE MASK AND PATIENT CIRCUIT ARE NOT AVAILABLE FOR INVESTIGATION. NO PRODUCT HAS BEEN RETURNED. THE PATIENT IS REPORTED TO HAVE BEEN RESTRAINED AT TIMES DUE TO VIOLENT BEHAVIOR, BUT IT IS UNKNOWN IF THE RESTRAINTS WERE IN PLACE AT THE TIME OF THE EVENT. ATTEMPTS TO GATHER FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. THE FITLIFE TOTAL FACE MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THIS MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE SMALL SIZE MASK IS TO BE USED ON PATIENTS 7 YEARS OR OLDER (>20 KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE LARGE AND EXTRA-LARGE SIZE MASKS ARE TO BE USED ON PATIENTS (>30 KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THIS MASK IS NOT SUITABLE FOR PROVIDING LIFE SUPPORT VENTILATION. THIS MASK SHOULD NOT BE USED FOR PATIENTS WHO ARE UNCOOPERATIVE, OBTUNDED, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK BY THEMSELVES. APPROPRIATE PATIENT MONITORING SHOULD BE USED AS MEDICALLY NECESSARY. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER IS UNABLE TO CONFIRM THE COMPLAINT THAT THE DISCONNECTION OF THE FITLIFE TOTAL FACE MASK FROM THE PATIENT CIRCUIT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE REGARDING THIS REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED AN ALLEGATION OF A PATIENT DEATH DUE TO INADVERTENT DISCONNECTION OF THE CIRCUIT AND MASK WHILE USING A TRILOGY VENTILATOR AND A FITLIFE TOTAL FACE MASK IN THE HOME. THE MANUFACTURER HAS REQUESTED RETURN OF THE FITLIFE MASK AND PATIENT CIRCUIT FOR INVESTIGATION. THE TRILOGY DEVICE IS NOT RETURNING TO THE MANUFACTURER. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910250 L FITLIFE MASK EE W/HGR JPN VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1075963

    Patients

    Seq Age Sex Outcome Treatment
    1 Death