BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO OXYGEN CONCENTRATOR

    MDR report key: 5809127 · Received July 20, 2016

    Report

    Report Number
    1040777-2016-00023
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    July 4, 2016
    Report Date
    July 5, 2016
    Manufacturer
    RESPIRONICS INC
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED THE SERIAL NUMBER TO THE AFFECTED EVERFLO OXYGEN CONCENTRATOR AS (B)(4), MODEL NUMBER 1020001. THE MANUFACTURER RECEIVED FOR EVALUATION AN EVERFLO OXYGEN CONCENTRATOR SERIAL NUMBER (B)(4), MODEL NUMBER 1020000. PHILIPS RESPIRONICS CONTACTED THE CUSTOMER AND CONFIRMED THAT THE EVERFLO OXYGEN CONCENTRATOR FOR THE EVENT DESCRIBED, MDR 1040777-2016-00023 IS THE EVERFLO OXYGEN CONCENTRATOR, SERIAL NUMBER (B)(4), MODEL NUMBER 1020000. THE CUSTOMER CONFIRMED THAT THEY ORIGINALLY PROVIDED THE INCORRECT INFORMATION.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR CAUGHT ON FIRE WHILE IN USE. THE PATIENT HAD DIFFICULTY BREATHING AND THE PARAMEDICS WERE CALLED. THERE WAS NO MEDICAL INTERVENTION REQUIRED FOR THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE HAS EVIDENCE OF THERMAL DAMAGE TO THE FRONT AND REAR CABINETS OF THE DEVICE. THERE WAS NO EVIDENCE OF THERMAL DAMAGE INTERNALLY. THE MANUFACTURER CONFIRMS THE FIRE WAS CAUSED BY AN EXTERNAL SOURCE. PRODUCT LABELING STATES, "OXYGEN VIGOROUSLY ACCELERATES COMBUSTION AND SHOULD BE KEPT AWAY FROM HEAT OR OPEN FLAME. NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE. DO NOT SMOKE, ALLOW OTHERS TO SMOKE OR HAVE OPEN FLAMES NEAR THE CONCENTRATOR WHEN IT IS IN USE." THE MANUFACTURER CONCLUDES THE FIRE WAS CAUSED BY AN EXTERNAL SOURCE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463553 EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS INC 1020001

    Patients

    Seq Age Sex Outcome Treatment
    1