PORTABLE 02 CONCENTRATOR TOC INDEPENDENCE GRE
Report
- Report Number
- MW5153112
- Event Type
- Injury
- Date Received
- March 22, 2024
- Date of Event
- March 1, 2024
- Report Date
- March 20, 2024
- Manufacturer
- O2 CONCEPTS, LLC
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
APRIA O2 CONC TOC INDEPENDENCE GRE. PORTABLE O2 DELIVERY SYSTEM USED FOR TRAVEL. I WAS ON A FLIGHT FROM (B)(6). THE UNIT FAILED TO OPERATE AS INDICATED AND MY O2 STAT DROPPED INTO THE 70'S CAUSING HEADACHE, SHORTNESS OF BREATH AND DIZZINESS MID AIR. THE FLIGHT ATTENDANTS HAD TO COME TO HELP AND DEPLOY THEIR O2 DEVICE SO THAT I COULD GET ADEQUATE OXYGEN. THIS UNIT DOES NOT WORK AS INTENDED ON BATTERY OR WHEN PLUGGED INTO THE POWER OUTLET. THE COMPANY WAS NOTIFIED UPON MY RETURN AND THEY HAVE NOT RETURNED A PHONE CALL AND ARE UNRESPONSIVE. PRIOR TO THIS INCIDENT THERE WERE MULTIPLE FAILURES AS WELL AND COMPANY WAS NOTIFIED AND THEY REQUESTED FOR ME TO DRIVE AN HOUR AWAY WITH A FAILING PRODUCT TO EXCHANGE IT. THAT WAS NOT FEASIBLE AS I COULDN'T RELY ON THEIR PRODUCT TO KEEP ME ALIVE. VERY STRESSFUL TRIP FILLED WITH ANXIETY. LUCKILY I PACKED MY PORTABLE UNIT THAT ONLY DELIVERS O2 ON PULSE AND USED THAT WHEN THIS PRODUCT FAILED. MY CONCERN IS / WAS THIS PRODUCT TESTED ON AN AIRPLANE ? WAS THIS PRODUCT TESTED IN THE CAR USING THE ADAPTER AND CIGARETTE LIGHTER ? EVEN WITH A FULL BATTERY CHARGE SYSTEM WOULD NOT OPERATE AS DESIGNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426943 | PORTABLE 02 CONCENTRATOR TOC INDEPENDENCE GRE | GENERATOR, OXYGEN, PORTABLE | CAW | O2 CONCEPTS, LLC | 800-0001-1-GE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Required Intervention| L |