Inogen At Home Stationary ConcentratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00817131020131), received between Mar 30, 2022 and Sep 2, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “No Flow” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Insufficient Flow or Under Infusion

  Patient problems: Dyspnea

  MAUDE report 50572010 ↗
• InjuryMay 14, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE BREATHING WITH THEIR STATIONARY DEVICE DUE TO A SENSOR ISSUE. A REPLACEMENT DEVICE WAS PROVIDED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Dyspnea

  MAUDE report 25173317 ↗
• InjuryJul 22, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025, THE PATIENT CALLED INGOEN, TO REPORT THAT THE YELLOW LIGHT APPEARED THERE WAS NO OXYGEN OUTPUT ON HIS GS HOME CONCENTRATOR. THE PAITENT STATED 911 WAS CALLED AND HE WAS TAKEN TO THE HOSPITAL BUT WAS NOT ADMITTED. THE INOGEN TEAM ATTEMPTED TO CONTACT PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE. INTERVENTION IS UNKNOWN.

  Patient problems: Dyspnea

  MAUDE report 22567003 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT EXPERIENCED A CRITICAL EVENT INVOLVING A HOME OXYGEN CONCENTRATOR. THE DEVICE REPORTEDLY STOPPED PRODUCING OXYGEN, PROMPTING THE PATIENT'S SPOUSE TO CONTACT EMERGENCY MEDICAL SERVICES. THE PATIENT, WHO RELIES ON CONTINUOUS OXYGEN THERAPY DUE TO CHRONIC COPD AND OTHER MEDICAL CONDITIONS, WAS TRANSPORTED TO THE EMERGENCY ROOM WITH CRITICALLY LOW OXYGEN LEVELS. UPON ARRIVAL, HER OXYGEN SATURATION WAS RECORDED AT ZERO, LEADING TO HOSPITAL ADMISSION. THE SPOUSE REPORTED THAT THE DEVICE COULD NOT FUNCTION BEYOND LEVEL 2, PARTICULARLY DURING NIGHTTIME USAGE AT LEVELS 2-3. ALTHOUGH AUDIBLE ALARMS WERE NOTED, THERE WERE NO VISUAL ALERTS AT THE TIME OF THE INCIDENT. THE PATIENT UTILIZED AN ALTERNATIVE OXYGEN SUPPLY DURING THE DEVICE MALFUNCTION. A REPLACEMENT UNIT WAS DISPATCHED WITHIN THREE DAYS, THOUGH THE PATIENT REMAINS HOSPITALIZED.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21688899 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT REPORTED A MALFUNCTION WITH THE INOGEN AT HOME UNIT. SHE WAS EXPERIENCING DIFFICULTY BREATHING, WITH A RAPID RESPIRATORY RATE AND AN OXYGEN LEVEL OF 82% WHILE USING HER PORTABLE OXYGEN CONCENTRATOR (POC). DUE TO HER CONDITION, THE PATIENT WAS UNABLE TO TROUBLESHOOT THE ISSUE AND REQUESTED THAT 911 BE CALLED. A REPORTABILITY ASSESSMENT WAS COMPLETED, AND ALL REQUIRED REPORTING SUBMISSIONS WERE MADE. THREE SUBSEQUENT ATTEMPTS BY INOGEN WERE MADE TO CONTACT THE PATIENT BUT WERE UNSUCCESSFUL.

  Patient problems: Dyspnea

  MAUDE report 21688677 ↗
• MalfunctionFeb 13, 2025No Flow; No Flow

  ACCORDING TO THE PATIENT, THE HOME UNIT WAS NOT WORKING. SHE DESCRIBED THAT THE DEVICE STARTED TO FLASHLIGHTS AND THEN STOPPED WORKING. SHE SAID THAT SHE WAS HAVING DIFFICULTY BREATHING. HER O2 HAD DROPPED TO 82% WHICH CAUSES HER TO GO TO THE HOSPITAL WHERE SHE STAYED FOR 3 DAYS. SHE REPORTED THAT SHE DID HAVE A PORTABLE UNIT AS AN ALTERNATIVE OXYGEN SUPPLY. AT THE HOSPITAL SHE RECEIVED BREATHING TREATMENT AND SUPPLEMENTAL OXYGEN WITH ANTIBIOTICS. THE PATIENT HAS A HISTORY OF CONGESTED HEART FAILURE, COPD AND EMPHYSEMA. THE PATIENT RECEIVED A REPLACEMENT 2 DAYS AFTER THE EVENT.

  Patient problems: Hypoxia

  MAUDE report 21379064 ↗
• MalfunctionNov 19, 2024No Flow; No Flow

  ACCORDING TO THE PATIENT, THE UNIT HAD A SYSTEM ERROR, RED ALARM, 5 BEEPS AND AN O2 ERROR. THE PATIENTS CLAIMS THAT THEIR O2 LEVELS DROPPED DUE TO THE POC NOT WORKING. THE PATIENT STATED THAT THERE WAS NO OTHER SOURCE OF O2. THE PATIENT HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Hypoxia

  MAUDE report 20719988 ↗
• MalfunctionJul 12, 2024Failure to Power Up; No Flow; Failure to Power Up; No Flow

  ACCORDING TO THE PATIENT, BOTH THE STATIONARY AND PORTABLE OXYGEN CONCENTRATORS WERE BOTH MALFUNCTIONING WHILE THE PATIENT WAS HOME. THE PATIENT HAD NO SOURCE OF OXYGEN INCLUDING ANY BACK UP OR ALTERNATIVE OXYGEN SUPPLIES. THE PORTABLE HAD NO AIR FLOW AND THE STATIONARY WOULD SHUT OFF AND WOULD NOT STAY ON. SO, THE PATIENT'S DAUGHTER PROCEEDED TO CALL 911 AND THE PATIENT WENT TO THE HOSPITAL. THE PATIENT WAS IN THE HOSPITAL FOR ONE WEEK AND A HALF. THE PATIENTS DAUGHTER BELIEVES THAT DUE TO THE LOW OXYGEN, HER MOTHER HAD A STROKE. THE HOSPITAL PROCEEDED WITH BREATHING TREATMENT AND OXYGEN. THE PATIENT IS NOW HOME AND DOING OKAY.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 19730549 ↗
• InjuryMar 30, 2022Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED LOW OXYGENATION. REPORTEDLY, THE PATIENT'S DEVICE STOPPED PUTTING OUT OXYGEN. AS A RESULT, THE PATIENT WAS TAKEN TO HOSPITAL VIA EMS. IN TURN, THE PATIENT WAS DISCHARGED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13951475 ↗