MAUDE Adverse Event Report: CAIRE INC. AIRSEP FOCUS PORTABLE OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number AS078-1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypoxia (1918)

Event Date 06/26/2018

Event Type  Injury  

Event Description

I had purchased a portable oxygen concentrator from (b)(6) at the end of (b)(6) to use on upcoming flights as i have a disability where i need a minimum of 4lpm of oxygen delivery.My dr sent in a prescription to the company stating the need for 4lpm.Being new to needing anything like this, i knew nothing about them.So i went to (b)(6) online and attempted to purchase the airsep focus model based on it's price.At first the company did not receive the prescription, so they would not sell me the product.I had my dr resend the prescription at which time the company sold me the aforementioned product.Upon using the product in flight, i became hypoxic and suffered for days recovering.On the return flight the same thing happened.So it wasn't until after attempting to use the product for the medical need prescribed, that i found the product sold to me was insufficient.The company sold me a 2lpm device when my prescription clearly stated 4lpm.So i was only receiving half the oxygen i needed.Not only that, i've found that if a 4lpm is required, the device necessary should at least deliver 5lpm.I'm curious as to the regulations of a company selling medically necessary devices to disabled consumers that are actually "under rated" in capability per their prescribed needs.Does the prescription have no bearing? i've tried reaching out to (b)(6) on numerous occasions and because it had been past 30 days (i did only need it for flight purposes hence the time frame), they will not work with me on upgrading or returning the device or anything else for that matter.Shouldn't their professional staff that deals with these devices every day been flagged to the lack of capacity this device would provide given my prescription? is it legal to sell a medical device that delivers less than what is prescribed and not notify the pt/consumer? i had to find out the hard way.Dose or amount: 15 inhalation(s), frequency: during flights, route: inhalation.Dates of use: 6 hrs.Diagnosis or reason for use: needed to avoid hypoxic reaction during flights.Event reappeared after reintroduction.

• Brand Name: AIRSEP FOCUS PORTABLE OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): CAIRE INC.
• MDR Report Key: 7850571
• MDR Text Key: 119645794
• Report Number: MW5079600
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS078-1
• Device Catalogue Number: 20913612_E
• Device Lot Number: LA417-1-C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 54 YR
• Patient Weight: 86