BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILBISS

    MDR report key: 14654357 · Received June 10, 2022

    Report

    Report Number
    2515872-2022-00114
    Event Type
    Death
    Date Received
    June 10, 2022
    Date of Event
    February 23, 2022
    Report Date
    January 24, 2023
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    UDI-DI
    00885304022466
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED BY HEALTH CANADA ABOUT AN INCIDENT THAT OCCURRED ON (B)(6) 2022, DURING WHICH A PATIENT USING A DEVILBISS 10 LITER OXYGEN CONCENTRATOR DIED FOLLOWING EQUIPMENT SHUTDOWN DURING A POWER OUTAGE. DEVILBISS IDENTIFIED THE DISTRIBUTOR OF THE UNIT AS MEDIGAS, AND IMMEDIATELY CONTACTED MEDIGAS TO INVESTIGATE. DEVILBISS HAS CONFIRMED THAT MEDIGAS IS NOW IN POSSESSION OF THE UNIT, AND WILL PROVIDE ADDITIONAL INFORMATION, INCLUDING THE SERIAL NUMBER OF THE UNIT AND ACCESS TO THE UNIT FOR PURPOSES OF EVALUATION AND TESTING, SHORTLY. DRIVE INTENDS TO TRACE ALL INTERNAL DOCUMENTS REGARDING THE UNIT AS SOON AS WE RECEIVE THE SERIAL NUMBER, AND WILL ALSO ARRANGE TO INSPECT, EVALUATE AND TEST THE UNIT AS SOON AS POSSIBLE.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED BY HEALTH CANADA ABOUT AN INCIDENT THAT OCCURRED ON (B)(6) 2022, DURING WHICH A PATIENT USING A DEVILBISS 10 LITER OXYGEN CONCENTRATOR DIED FOLLOWING EQUIPMENT SHUTDOWN DURING A POWER OUTAGE. DEVILBISS IDENTIFIED THE DISTRIBUTOR OF THE UNIT AS MEDIGAS, AND IMMEDIATELY CONTACTED MEDIGAS TO INVESTIGATE. THE DEVICE WAS OBTAINED BY DEVILBISS FOR EVALUATION WHERE IT WAS DETERMINED THAT THE UNIT WAS OPERATING TO SPECIFICATION, INCLUDING THE POWER FAILURE ALARM. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION, UNIT OPERATED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195109 DEVILBISS OXYGEN CONCENTRATOR CAW DEVILBISS HEALTHCARE LLC 1025DS 00885304022466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death