BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEVILIBSS HEALTHCARE

    MDR report key: 18988928 · Received March 27, 2024

    Report

    Report Number
    2515872-2024-00017
    Event Type
    Death
    Date Received
    March 27, 2024
    Date of Event
    January 9, 2024
    Report Date
    December 17, 2024
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DRIVE DEVILBISS PREVIOUSLY REPORTED AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A DEALER IN GERMANY, WHO REPORTED THAT A 14-MONTH-OLD CHILD PASSED AWAY WHILE USING THE DEVICE. THE DEVICE'S INSTRUCTION GUIDE CONTAINS THE FOLLOWING WARNING: "GERIATRIC, PEDIATRIC OR ANY OTHER PATIENT UNABLE TO COMMUNICATE DISCOMFORT CAN REQUIRE ADDITIONAL MONITORING AND/OR A DISTRIBUTED ALARM SYSTEM TO CONVEY THE INFORMATION ABOUT THE DISCOMFORT AND/OR THE MEDICAL URGENCY TO THE RESPONSIBLE CAREGIVER TO AVOID HARM." IT IS UNCLEAR WHETHER SUCH ADDITIONAL MONITORING OR ALARM SYSTEM WAS IN PLACE. IT IS LIKEWISE UNCLEAR WHETHER THE DEVICE WAS FITTED WITH THE APPROPRIATE FLOW METER FOR PEDIATRIC USE. THE DEVICE HAS BEEN RETAINED BY AUTHORITIES IN GERMANY FOR INVESTIGATION. DRIVE DEVILBISS RECEIVED A LETTER FROM THE ZWEIBRÜCKEN PUBLIC PROSECUTOR'S OFFICE DATED 27.09.2024 ON INVESTIGATION PROCEEDINGS 4129. ACCORDING TO THE CURRENT STATE OF THE INVESTIGATION, THE PUBLIC PROSECUTOR'S OFFICE CONFIRMED THAT THE DEATH AT ISSUE IN THE PROCEEDINGS WAS NOT RELATED TO THE OPERATION OF THE OF THE OXYGEN CONCENTRATOR OF DEVILBISS HEALTHCARE LLC. THERE IS NO EVIDENCE OF A MALFUNCTION OR INCORRECT OPERATION OF THE OXYGEN CONCENTRATOR.

    Additional Manufacturer Narrative · 0

    THE PREVIOUSLY SUBMITTED REPORT HAD LACKING OR INCORRECT INFORMATION IN SECTION D4 UDI. SECTION D4 HAS BEEN UPDATED WITH THE CORRECT INFORMATION.

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A DEALER IN GERMANY, WHO REPORTED THAT A 14-MONTH-OLD CHILD PASSED AWAY WHILE USING THE DEVICE. THE DEVICE'S INSTRUCTION GUIDE CONTAINS THE FOLLOWING WARNING: "GERIATRIC, PEDIATRIC OR ANY OTHER PATIENT UNABLE TO COMMUNICATE DISCOMFORT CAN REQUIRE ADDITIONAL MONITORING AND/OR A DISTRIBUTED ALARM SYSTEM TO CONVEY THE INFORMATION ABOUT THE DISCOMFORT AND/OR THE MEDICAL URGENCY TO THE RESPONSIBLE CAREGIVER TO AVOID HARM." IT IS UNCLEAR WHETHER SUCH ADDITIONAL MONITORING OR ALARM SYSTEM WAS IN PLACE. IT IS LIKEWISE UNCLEAR WHETHER THE DEVICE WAS FITTED WITH THE APPROPRIATE FLOW METER FOR PEDIATRIC USE. THE DEVICE HAS BEEN RETAINED BY AUTHORITIES IN GERMANY FOR INVESTIGATION. DEVILBISS HAS CONTACTED THE INVESTIGATING AUTHORITIES, AND IS AWAITING FURTHER INFORMATION AND AN OPPORTUNITY TO EVALUATE THE PRODUCT. DEVILBISS WILL UPDATE THIS REPORT WITH ANY FURTHER INFORMATION THAT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436272 DEVILIBSS HEALTHCARE GENERATOR, OXYGEN, PORTABLE CAW DEVILBISS HEALTHCARE LLC 525KS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Unknown Death