BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLO

    MDR report key: 17516393 · Received August 11, 2023

    Report

    Report Number
    MW5123342
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    August 15, 2012
    Report Date
    September 6, 2012
    Manufacturer
    PHILIPS-RESPIRONICS
    Product Code
    CAW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LNOGEN INC., HAS RECEIVED NOTIFICATION OF A POTENTIALLY REPORTABLE THREATENING EVENT REGARDING PATIENT USE OF A STATIONARY OXYGEN CONCENTRATOR MEDICAL DEVICE THAT IS NOT MANUFACTURED BY LNOGEN. THE STATIONARY OXYGEN CONCENTRATOR IS MANUFACTURED BY PHILIPS-RESPIRONICS, EVERFLO MODEL, SERIAL NUMBER (B)(6). THIS DEVICE IS NOT MANUFACTURED BY LNOGEN INC. ATTACHED IS INITIAL RECORD TAKEN OF THE INCIDENT BY LNOGEN'S CLIENT SERVICE REPRESENTATIVE. PATIENT CALLED TO INFORM US THAT HER BU UNIT HAD CAUGHT ON FIRE. SHE STATES THAT SHE LEFT THE ROOM THAT IT WAS IN FOR 3 MIN. AND UPON RETURN THE ROOM WAS FILLED WITH SMOKE AND IT WAS BILLOWING OUT OF THE BOTTOM OF THE MACHINE. SHE THEN SAW THAT THE TUBING WAS ON FIRE SO SHE GRABBED A BLANKET FROM HER BED TO SMOTHER THE FIRE. SHE UNPLUGGED THE UNIT AND PROCEEDED TO TAKE IT OUTSIDE. SHE STATES HER CARPET UNDERNEATH WHERE THE UNIT SAT HAS BURN DAMAGE. SHE REPORTS NO INJURIES OR DAMAGE OTHER THAN THE UNIT, THE CARPET, AND THE BLANKET THAT WAS USED TO PUT THE FIRE OUT. N/A THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233742 EVERFLO GENERATOR, OXYGEN, PORTABLE CAW PHILIPS-RESPIRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown