BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCENTRATOR, DRIVE, OCI

    MDR report key: 6602758 · Received May 31, 2017

    Report

    Report Number
    1062191-2017-00008
    Event Type
    Death
    Date Received
    May 31, 2017
    Date of Event
    February 25, 2017
    Report Date
    April 25, 2017
    Manufacturer
    INOVO INC.
    Product Code
    CAW
    PMA / PMN Number
    K080391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTENDED USE OF THE PURE OXYGEN CONCENTRATOR IS TO PROVIDE SUPPLEMENTAL OXYGEN TO THOSE INDIVIDUALS NEEDING SUPPLEMENTAL OXYGEN THERAPY. THE DEVICE IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. THERE IS NO INFORMATION REGARDING THE PATIENT'S ACTUAL OXYGEN PRESCRIPTION BUT THE MAJORITY OF HOME OXYGEN USERS IN THE US ARE PRESCRIBED 2 OR 3 LITERS PER MINUTE VIA NASAL CANNULA AS A SUPPLEMENTAL TREATMENT FOR MILD TO MODERATE HYPOXEMIA. UPON OBTAINING FURTHER INFORMATION FROM THE INITIAL REPORTER, IT WAS REPORTED THAT THE PATIENT'S DEATH OCCURRED SEVERAL (4-5) DAYS AFTER THE INDIVIDUAL WAS ADMITTED TO THE HOSPITAL, WHICH IS THE SAME TIME FRAME AFTER DISCONTINUING USE OF THE PURE CONCENTRATOR. THE INITIAL REPORTER ADMITS HE HAS NO ACTUAL KNOWLEDGE IF THE DEVICE CAUSED ILLNESS OR DEATH OF THE PATIENT AND NO KNOWLEDGE OF ANY COMPLAINT FROM THE PATIENT, FAMILY OR MEDICAL PROFESSIONALS STATING OR SUGGESTING THE PURE CONCENTRATOR MALFUNCTIONED IN ANY WAY AND/OR CONTRIBUTED TO OR CAUSED ILLNESS OR DEATH OF THE PATIENT. THE DATA PRESENT TO DATE SUGGEST THERE IS NO INDICATION OF A CORRELATION BETWEEN THE REPORTED INCIDENT AND THE PURE CONCENTRATOR. THE INVESTIGATION REGARDING THE ISSUE WILL CONTINUE.

    Description of Event or Problem · 1

    A LETTER WAS RECEIVED FROM FDA REFERENCING REPORT MW5069076 WAS RECEIVED (B)(6) 2017. THE EVENT DESCRIPTION INCLUDED THAT AN OXYGEN CONCENTRATOR MADE BY DRIVE HAS CAUSED ILLNESS AND DEATH TO A PATIENT AT MY COMPANY. I HAVE REPORTED THE CASE TO MY EMPLOYER AND TO DRIVE. NEITHER COMPANY HAS MADE AN EFFORT TO TEST OR RECALL THE EQUIPMENT. I HAVE PERSONALLY FOUND 3 DRIVE CONCENTRATORS THAT ARE NOT CREATING OXYGEN AND THE MACHINE IS NOT ALARMING OR SIGNALING THE PATIENT. DRIVE INSTRUCTED MY COMPANY TO THROW THE MACHINES AWAY AND WILL REPLACE THEM. MY COMPANY STILL HAS MANY OF THESE MACHINES IN PATIENT'S HOME AND HAVE NOT RECALLED THEM, EVEN AFTER MY REQUESTS TO DO SO. THE CONCENTRATOR REFERENCED IN THE LETTER WAS MANUFACTURED BY INOVO, INC. THIS WAS THE FIRST NOTIFICATION RECEIVED BY INOVO OR DRIVE REGARDING THE ISSUE. INOVO CONTACTED THE INITIAL REPORTER ON (B)(6) 2017 USING THE CONTACT INFORMATION INCLUDED IN THE LETTER. THE INITIAL REPORTER IS A DELIVERY TECHNICIAN AND PROVIDED ADDITIONAL INFORMATION REGARDING THE ISSUE, STATING HE DOES NOT KNOW NOR HAVE ANY EVIDENCE OF WHAT CAUSED THE PATIENT TO BE ADMITTED TO THE HOSPITAL; HE LEARNED OF THE PATIENT'S ADMISSION FROM THE PATIENT'S WIFE DURING A DELIVERY OF MEDICAL EQUIPMENT. THE INITIAL REPORTER CONFIRMED THAT HE HAS NO OBJECTIVE INFORMATION OR DATA SUGGESTING THE PURE CONCENTRATOR WAS MALFUNCTIONING AT THE TIME THE PATIENT WAS ADMITTED OR IF THE PATIENT'S MEDICAL CONDITION AND SUBSEQUENT DEATH WAS IN ANY WAY RELATED TO THE PURE OXYGEN CONCENTRATOR. HE HAD INITIALLY REPORTED HIS CONCERNS TO HIS EMPLOYER, WHO DETERMINED THAT IT WAS NOT AN ADVERSE EVENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S DEATH OCCURRED SEVERAL (4-5) DAYS AFTER THE INDIVIDUAL WAS ADMITTED TO THE HOSPITAL, WHICH IS THE SAME TIME FRAME AFTER DISCONTINUING USE OF THE PURE CONCENTRATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382503 CONCENTRATOR, DRIVE, OCI PURE OXYGEN CONCENTRATOR CAW INOVO INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death