BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVILBISS

    MDR report key: 18764085 · Received February 22, 2024

    Report

    Report Number
    2515872-2024-00010
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 17, 2024
    Report Date
    December 16, 2024
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    CAW
    PMA / PMN Number
    K071397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. THE DEVICE MANUFACTURER DATE IN SECTION H4 WAS INCORRECTLY SUBMITTED IN THE PREVIOUS REPORT. H4 HAS BEEN UPDATED WITH THE CORRECT INFORMATION.

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY MEDWATCH # (B)(4) FROM VITAS HEALTHCARE, WHICH REPORTED THAT A PATIENT WAS SMOKING WITH OXYGEN ON AND SUSTAINED 2ND AND 3RD DEGREE BURNS TO THE FACE, HEAD, NECK AND CHEST, TOTALING 6% OF THE BODY SURFACE. THE PATIENT WAS TRANSFERRED TO A BURN UNIT AND VENTILATED. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN THE INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE THE CANNULA AND LEAVE THE ROOM WHERE EITHER THE CANNULA OR MASK OR THE OXYGEN CONCENTRATOR IS LOCATED. IF UNABLE TO LEAVE THE ROOM, YOU MUST WAIT 10 MINUTES AFTER YOU HAVE TURNED OFF THE OXYGEN CONCENTRATOR BEFORE SMOKING. OXYGEN MAKES IT EASIER FOR A FIRE TO START AND SPREAD. DO NOT LEAVE THE NASAL CANNULA OR MASK ON BED COVERINGS OR CHAIR CUSHIONS IF THE OXYGEN CONCENTRATOR IS TURNED ON BUT NOT IN USE. THE OXYGEN WILL MAKE THE MATERIALS FLAMMABLE. TURN THE OXYGEN CONCENTRATOR OFF WHEN NOT IN USE TO PREVENT OXYGEN ENRICHMENT. KEEP THE OXYGEN CONCENTRATOR AND CANNULA AT LEAST 2 M (6.5 FEET) FROM HOT, SPARKING OBJECTS OR NAKED SOURCES OF FLAME. OPEN FLAMES DURING OXYGEN THERAPY ARE DANGEROUS AND ARE LIKELY TO RESULT IN FIRE OR DEATH. DO NOT ALLOW OPEN FLAMES WITHIN 2 M (6.5 FEET) OF THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES. DRIVE DEVILBISS OXYGEN CONCENTRATORS ARE EQUIPPED WITH A FIRE MITIGATING OUTLET FITTING THAT PREVENTS PROPAGATION OF FIRE INTO THE UNIT." DEVILBISS HEALTHCARE WILL UPDATE THIS REPORT SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227641 DEVILBISS GENERATOR, OXYGEN, PORTABLE CAW DEVILBISS HEALTHCARE LLC 525DS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| L