Inogen One G5 Portable Oxygen Concentrator

Description of Event or Problem

It was reported that the patient's device had shut off by itself while the patient was out at a restaurant. It was noted that the System Hot error message was seen. As a result, the patient got into an "emergency." A replacement device was sent. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

Additional Manufacturer Narrative

The Inogen Team attempted to contact the patient for further information three times with no response.The unit was returned with a System Hot complaint, which was confirmed during testing. The unit "system hot" shutdown because fan was misaligned and contacting the accumulator likely due to high-impact incident, possibly from the unit being dropped. Also, the muffler being filled with dust, which resulted in a blockage in the feed port and leak from cannula receptacle due to the high impact to the unit. Furthermore, the PSA cycle (according to the Data Log) being high (14) is an indication the zeolite is getting contaminated by moisture. UIP, Top Housing & Lower Housing were also replaced due to cosmetic damage.