BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN CONCENTRATOR

    MDR report key: 18567979 · Received January 23, 2024

    Report

    Report Number
    3016809216-2024-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    December 8, 2023
    Report Date
    April 23, 2024
    Manufacturer
    GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LT
    Product Code
    CAW
    UDI-DI
    00815027012512
    PMA / PMN Number
    K191875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON 8/1/2024, (B)(6) FROM OUR BUSINESS DEPARTMENT RECEIVED THE AMERICAN CUSTOMER DALTON MEDICA MAIL (FEEDBACK INFORMATION NO.: (B)(4)) FEEDBACK, THAT IS, THERE ARE USERS COMPLAINED ABOUT THE PURCHASE OF OXYGEN CONCENTRATOR PRODUCT FIRE, PRODUCT MODEL: R-DOC5200, SERIAL NUMBER (B)(6), AND PROVIDED THE PICTURES OF THE SHELL OF THE PRODUCT THAT HAD CAUGHT FIRE. AFTER RECEIVING THE EMAIL, LOUIS FROM SALES DEAPRTMENT ASKED DALTON MEDICA BY EMAIL ON 12/1/2024 FOR INFORMATION RELATED TO THIS INCIDENT AS FOLLOWS : A. INQUIRING WHETHER DALTON MEDICA HAS REPORTED THE MDR ACCIDENT REPORT TO THE FDA AND IF SO, WHETHER THE CORRESPONDING MDR INCIDENT REPORT DOCUMENT CAN BE SENT TO US? B. ASKED DALTON MEDICA, DOES THE USERS COULD RETURN THE DEFECTIVE EQUIPMENT? C. WAS THE UNIT BEING TREATED WHEN IT CAUGHT FIRE? WHAT WAS THE USER'S FLOW RATE SETTING? D. WAS THE UNIT BEING TREATED WHEN IT CAUGHT FIRE? WHAT WAS THE USER'S FLOW RATE SETTING? E. WHAT PRODUCT COMPONENTS WERE DAMAGED AFTER THE FIRE IN THE EQUIPMENT? CAN THE EQUIPMENT BE REUSED? F. WAS IT POSSIBLE FOR THE USER TO RETURN THE EQUIPMENT TO US FOR INVESTIGATION AFTER THE FIRE? G. WERE ANY PATIENTS INJURED WHEN THE EQUIPMENT CAUGHT FIRE? H. DID THE EQUIPMENT FIRE RESULT IN DAMAGE TO OTHER PATIENT PROPERTY? AND INFORM DALTON MEDICA COMPANY TO NOTIFY THE USER TO SEAL THE PRODUCT AND ALSO SUGGEST DALTON MEDICA PROVIDE A NEW DEVICE FOR THE USER TO USE OR RETURN THE EQUIPMENT (MODEL: R-DOC5200, SERIAL NUMBER: (B)(6) TO THE MANUFACTURER FOR REPAIRS. HOWEVER, ON 20/1/2024, LOUIS RECEIVED AN EMAIL FROM DALTON MEDICA, WHICH ONLY PROVIDED THE FDA 3500A REPORT THAT THEY (AS THE IMPORTER) HAD FILED, WITH NO OTHER INFORMATION ABOUT THE USER OR THE USE OF THE DEVICE AT THE TIME OF THE FIRE. IN THE 3500A REPORT THAT DALTON MEDICA SUBMITTED TO THE FDA, THE DETAILS OF THE INCIDENT WERE DESCRIBED BELOW: ON 12/8/2023 DALTON HAS BEEN NOTIFIED BY CUSTOMER ADRIA GOMEX OF MEDME SERVICES CORPORATION IN EL PASO TX 79902. HE STATED THAT THE OXYGEN CONCENTRATOR THEY PURCHASED FROM DALTON WAS ON FIRE AND PATIENT IS A SMOKER. THE SERIAL NO. OF THE OXYGEN CONCENTRATOR IS (B)(6). AT THE SAME TIME, DALTON MEDICA INFORMED VIA EMAIL THAT THE NEW PRODUCT HAS BEEN PROVIDED TO THE USERS, BUT THEY ARE UNWILLING TO RETURN THE FAULTY EQUIPMENT. LOUIS FROM OUR BUSINESS DEPARTMENT FOUND THAT THE PRODUCT SERIAL NUMBER (B)(6) IN THE 3500A REPORT THAT DALTON MEDICA HAD SUBMITTED TO THE FDA DID NOT MATCH THE SERIAL NUMBER OF THE PRODUCT THAT THEY HAD SENT IN THEIR 8/1/2024 EMAIL. LOUIS THEN CONFIRMED WITH DALTON MEDICA AGAIN BY EMAIL ON 21/1/2024 THAT THE SERIAL NUMBER OF THE PRODUCT THAT CAUGHT FIRE WAS (B)(6). ON 22/1/2024, LOUIS INQUIRED ABOUT THE SALES ORDER LIST BASED ON THE SERIAL NUMBER OF THE PRODUCT, (B)(6), AND ASCERTAINED THAT THE ORDER NUMBER OF THE PRODUCT OF THE INCIDENT WAS: (B)(6), AND INITIALLY DETERMINED THAT THE BATCH NUMBER OF THE PRODUCT WAS 20230716.SU ZHAN HUI, R&D DEPARTMENT, SUBMITTED THE FDA 3500A REPORT ON THE BASIC OF TENTATIVELY CONFIRMED PRODUCT BATCH NUMBER ON 24/1/2024.

    Description of Event or Problem · 0

    ON 12/8/2023, DALTON HAS BEEN NOTIFIED BY CUSTOMER (B)(6), (B)(4). HE STATED THAT THE OXYGEN CONCENTRATOR THEY PURCHASED FROM DALTON WAS ON FIRE AND PATIENT IS A SMOKER. THE SERIAL NO. OF THE OXYGEN CONCENTRATOR IS (B)(6). HE DIDN'T RELEASE PATIENT INFORMATION TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953807 OXYGEN CONCENTRATOR OXYGEN CONCENTRATOR CAW GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LT R-DOC5200 20230715 00815027012512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown