BEUDAMED
    FDA Adverse Event Death Summary report: N

    HS 456

    MDR report key: 5005253 · Received August 5, 2015

    Report

    Report Number
    9681154-2015-00014
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    March 14, 2014
    Report Date
    August 12, 2016
    Manufacturer
    RESPIRATORY DRUG DELIVERY (UK) LTD.
    Product Code
    CAF
    PMA / PMN Number
    K924123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER HAS PERFORMED A VISUAL INSPECTION OF THE COMPRESSOR THAT APPEARS AS AN AGGLOMERATION OF PLASTIC AND METAL FUSED TOGETHER. HOWEVER, THERE ARE STILL RUBBER COMPONENTS WITHIN THE COMPRESSOR REMAINS INDICATING THAT VERY LIKELY THE COMPRESSOR SUSTAINED EXTERNAL HEAT THAT DISTORTED THE PLASTIC DEVICE BEFORE THERMALLY DAMAGING ANY OF THE INTERIOR COMPONENTS. FROM THE AVAILABLE PICTURES OF THE APARTMENT AFTER THE FIRE WAS EXTINGUISHED, IT APPEARS THAT IN THE SAME ROOM WHERE THE COMPRESSOR HAVE BEEN FOUND IT WAS PRESENT AN OXYGEN CONCENTRATOR AND CLEAR SIGN OF "BURNED TUBING" HAVE BEEN FOUND ON THE FLOOR VERY CLOSE TO WHERE THE COMPRESSOR WAS FOUND. THIS INDICATES THAT THE OXYGEN CONCENTRATOR WAS RUNNING AT THE TIME OF THE EVENT. IT IS LIKELY THAT THE COMPRESSOR POWER CORD PLUG WAS CONNECTED TO THE POWER SOCKET HOWEVER IS NOT POSSIBLE TO DETERMINE IF THE DEVICE WAS ENERGIZED OR NOT AT THE TIME OF THE EVENT. IF THE HS456 COMPRESSOR WAS RUNNING AT THE SAME TIME OXYGEN CONCENTRATOR WAS OPERATING THIS WOULD BE IN CONTRADICTION TO THE WARNING IN THE INSTRUCTION FOR USE OF THE DEVICE THAT STATES TO "DO NOT USE OUTDOORS OR OPERATE WHERE AEROSOL (SPRAY) PRODUCTS ARE BEING USED OR WHERE OXYGEN IS BEING ADMINISTERED IN A CLOSED AREA SUCH AS AN OXYGEN TENT". IN THE EVENTUALITY THAT THE COMPRESSOR WAS NOT RUNNING AT THE TIME OF THE EVENT WITH THE PLUG LEFT CONNECTED TO THE POWER SOCKET IT WOULD BE IN CONTRADICTION TO ONE OF THE "IMPORTANT SAFEGUARDS" IN THE INSTRUCTION FOR USE OF THE DEVICE THAT CALLS: "ALWAYS UNPLUG THE PRODUCT IMMEDIATELY AFTER USING". HS456 IS NO LONGER IN PRODUCTION. NO FURTHER FOLLOW-UP REPORTING WILL BE PROVIDED FOR THIS ISSUE UNLESS NEW INFORMATION BECAME AVAILABLE. CORRECTION: MANUFACTURER REPORT NUMBER IN THE INITIAL REPORT WAS 9681154-2015-00011 AND IT WAS NOT CORRECT. RIGHT NUMBER IS 9681154-2015-00014.

    Description of Event or Problem · 1

    PHILIPS INTERNAL REFERENCE NO: (B)(4). THE MANUFACTURER RECEIVED INFO ALLEGING AN HS456 COMPRESSOR HAS CAUSED FIRE TO A PROPERTY AND THERE WAS A DEATH (THE APARTMENT OCCUPANT) AS RESULT OF THE EVENT. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER BUT IT IS AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517587 HS 456 COMPRESSOR, AIR, PORTABLE CAF RESPIRATORY DRUG DELIVERY (UK) LTD. HS 456

    Patients

    Seq Age Sex Outcome Treatment
    1 Death