BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERFLO

    MDR report key: 17516440 · Received August 11, 2023

    Report

    Report Number
    MW5123389
    Event Type
    Death
    Date Received
    August 11, 2023
    Date of Event
    May 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    PHILIPS-RESPIRONICS
    Product Code
    CAW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE STATIONARY OXYGEN CONCENTRATOR IS MANUFACTURED BY PHILIPS-RESPIRONICS, EVERFLO MODEL, SERIAL NUMBER (B)(6). THIS DEVICE IS NOT MANUFACTURED BY INOGEN INC? ON (B)(6) 2014, (B)(6) CALLED THE PATIENT HOTLINE (877#) TO REPORT A PRODUCT MALFUNCTION. SHE CONNECTED WITH (B)(6), WHO WAS RUDE AND DISMISSIVE OF THE COMPLAINT. ON (B)(6) 2014, REPLACEMENT PRODUCT WAS SENT. ON (B)(6) 2014, (B)(6) CALLED THE PATIENT HOTLINE (877#) AND WAS TOLD, THERE WAS NO RECORD OF THE FURNISHING OF REPLACEMENT PRODUCT. THOUGH (B)(6) HAD RECEIVED EQUIPMENT WITH PACKING SLIP. ON (B)(6) 2014, (B)(6) PASSED AWAY. HIS PHYSICIAN STATED, THAT HIS DEATH MAY HAVE BEEN DUE TO LACK OF OXYGEN. (B)(6) 2014, (B)(6) WAS IN FREQUENT AND REGULAR CONTACT WITH LNOGEN. UPON REQUESTING TO BE TRANSFERRED TO SUPERVISOR(S), HER CALLS WERE REPEATEDLY DISCONNECTED AND UNRETURNED. (B)(4). 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
    2181907 EVERFLO GENERATOR, OXYGEN, PORTABLE CAW PHILIPS-RESPIRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown