BEUDAMED
    FDA Adverse Event Death Summary report: N

    1031452-2018-00014

    MDR report key: 8128668 · Received December 4, 2018

    Report

    Report Number
    1031452-2018-00014
    Event Type
    Death
    Date Received
    December 4, 2018
    Date of Event
    November 1, 2018
    Report Date
    November 6, 2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGED MALFUNCTION/DEFICIENCY WITH THE DEVICE. BASED ON THE INFORMATION PROVIDED, THE EVENT WAS A RESULT OF USE ERROR. THE PATIENT DID NOT ADHERE TO THE DEVICE LABELING AND INSTRUCTIONS. THE IRC5PO2V USER MANUAL STATES, "DO NOT SMOKE WHILE USING THIS DEVICE. DO NOT USE NEAR OPEN FLAME OR IGNITION SOURCES. NO SMOKING SIGNS SHOULD BE PROMINENTLY DISPLAYED. KEEP ALL MATCHES, LIGHTED CIGARETTES, ELECTRONIC CIGARETTES OR OTHER SOURCES OF IGNITION OUT OF THE ROOM IN WHICH THIS CONCENTRATOR IS LOCATED AND AWAY FROM WHERE OXYGEN IS BEING DELIVERED." IN ADDITION, THE DEVICE ITSELF IS PROMINENTLY LABELED REGARDING THE HAZARD OF SMOKING OR EXPOSING THE UNIT TO AN OPEN FLAME/IGNITION SOURCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE FACILITY TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT AND TO REQUEST THE RETURN OF THE DEVICE. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL; NO FURTHER COMMUNICATION HAS BEEN RECEIVED FROM THE FACILITY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED FROM A FACILITY ALLEGING THAT THE PATIENT WAS SMOKING WHILE USING AN IRC5PO2V CONCENTRATOR, CAUSING A FIRE. THE FACILITY STATED THAT THEY FOUND THE PATIENT IN BED WITH HIS OXYGEN ON, THE MATTRESS WAS ON FIRE, AND THERE WERE FLAMES ON THE PATIENT'S CLOTHES. THE PATIENT SUSTAINED 2ND AND 3RD DEGREE BURNS TO 30% OF HIS BODY ON THE LEFT SIDE. HE WAS TRANSFERRED TO A HOSPITAL ICU BURN UNIT, AND HE SUBSEQUENTLY DIED.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H