EverFlo EVERFLO QUIET w/O2 Percent Indicator, 120V, US, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00606959032620), received between Nov 21, 2017 and Mar 3, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026No Audible Alarm; Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED SEVERE SHORTNESS OF BREATH WHILE USING AN EVERFLO DEVICE. THE PATIENT'S SPOUSE CALLED THE EMT WHO CHECKED THE DEVICE. THE DEVICE HAD NO FLOW COMING FROM THE OUTLET. THE DEVICE SETTINGS DURING THE EVENT WERE REPORTED TO BE 4.5-5L AND A GREEN LIGHT WAS SHOWING. THERE WERE NO AUDIBLE OR VISUAL ALARMS AT THE TIME. THE PATIENT IS CURRENTLY HOSPITALIZED. THE DEVICE WAS EVALUATED BY THE SERVICE TECHNICIAN. DURING THE EVALUATION IT WAS FOUND THAT THE NIPPLE ON THE FINAL BACTERIAL FILTER (BETWEEN THE FLOW METER AND PATIENT OUTLET) HAD SNAPPED IN HALF, THUS DELIVERING THE OXYGEN TO THE INSIDE OF THE MACHINE AND NOT THE PATIENT, HOWEVER, NO ALARM CONDITIONS OCCURRED. THE DEVICE HAS BEEN FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Dyspnea

  MAUDE report 24503294 ↗
• MalfunctionJun 6, 2024Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO QUIET THAT THE PATIENT ALLEGING FAULTY PARTS. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, THE SIEVE WAS LEAKING, THE FLOW METER WAS CRACKED, CONCENTRATOR TUBING WAS BRITTLE, COMPRESSOR WAS FAILING, POWER CORD WAS SPLIT OPEN AND FAULTY PARTS WERE REPLACED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476349 ↗
• MalfunctionJan 19, 2024Device Alarm System; Crack; Failure to Deliver; Gas/Air Leak; Intermittent Loss of Power; Device Alarm System; Crack; Failure to Deliver; Gas/Air Leak; Intermittent Loss of Power

  THE MANUFACTURER WAS CONTACTED ABOUT AN EVERFLO OXYGEN CONCENTRATOR. PER THE WORK ORDER RECEIVED BY THE FASC THE SIEVES BEDS WERE BLOWN, SOLENOID INTERMITTENT, THE REGULATOR WAS LEAKING, THE COMPRESSOR RATTLING, THE PCA BOARD HAD LIGHTS, AND THE POWER CORD WAS CUT OFF. THERE WAS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO CLINICAL INFORMATION OR MEDICAL INFORMATION WAS SPECIFIED. THE FASC PERFORMED A COMPREHENSIVE INSPECTION AND REPLACED THE NECESSARY PARTS. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546156 ↗
• MalfunctionJan 17, 2024Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF EVERFLO QUIET THAT THE PATIENT ALLEGES THAT THE DEVICE IS ALARMING. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT THAT THE COMPLAINT WAS CONFIRMED, THE SIEVE BEDS BLOWN, THE SOLENOID WAS INTERMITTENT, THE REGULATOR WAS DAMAGED, PCA BOARD HAS NON-STOP ALARMING, FLOW METER WAS CRACKED, AND POWER CORD WAS SMASHED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530827 ↗
• MalfunctionJan 2, 2024Leak/Splash; Leak/Splash

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A EVERFLO QUIET DEVICE. THE DEVICE WAS SERVICED BY A FIELD SERVICE TECHNICIAN. DURING THE EVALUATION OF THE DEVICE HAD A SIEVE BED SMELL THAT WAS REPLACED FOR PREVENTATIVE MAINTENANCE. THE INLET FILTER WAS DIRTY, THE MANIFOLD ASSEMBLY WAS LEAKING AND THE SHIPPING BOX WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18431183 ↗
• MalfunctionNov 21, 2017Fire; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERFLO OXYGEN CONCENTRATOR WAS INVOLVED IN A HOUSE FIRE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7049010 ↗