SimplyGo Mini SimplyGo Mini, Standard Battery, JPRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00606959047440), received between Nov 7, 2021 and Mar 20, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Sparking

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLYGO MINI DEVICE. THERE WAS AN ALLEGATION OF CHARGING CONNECTOR HAD DETERIORATED, AND THE CABLE HAD BROKEN NEAR THE CONNECTION POINT. THE CABLE WAS REPLACED WITH A NEW ONE. WHEN IT WAS CONNECTED TO AN OUTLET IN THE OFFICE AS A TEST, A SPARKING SOUND WAS OBSERVED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER INVESTIGATION IS ONGOING. A FOLLOW REPORT WILL BE SUBMITTED WHEN MANUFACTURER INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653949 ↗
• MalfunctionFeb 12, 2026Smoking

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLY GO MINI DEVICE WITH AN ALLEGATION USING A CAR CIGARETTE LIGHTER SOCKET, SMOKE CAME OUT OF THE SOCKET (ON THE CAR SIDE) MACHINE. THE DEVICE TURNS OFF BUT THE STANDBY SYMBOL REMAINS DISPLAYED. THE PATIENT PULLED IT OUT OF THE SOCKET, SO NOTHING HAPPENED. AT THE SITE, THE CABLE AND EQUIPMENT OF THE SEGA SOCKET WERE NOT TURNED OFF. SINCE THE CONDITION WAS POOR, THEY DECIDED TO REPLACE IT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321516 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT WAS IN HOSPITAL DUE TO HIS SPO2 TEMPORARILY DROPPED TO 77% BUT AFTER SWITCHING TO OXYGEN INHALATION, IT RECOVERED TO AROUND 95%. THE REPORT SAID THAT THE DEVICE ALARMED CHANGE TO ANOTHER SOURCE OF OXYGEN THUS LEADING TO THE PATIENT BEING PLACED ON O2 AND RECOVERING FROM SYMPTOMS. THEREFORE, THE DEVICE WORKED AS INTENDED BY LETTING THE PATIENT KNOW OXYGEN WAS LOW AND A DIFFERENT SOURCE WAS NEEDED. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE WAS EVALUATED, DURING THE EVALUATION OF THE DEVICE WAS VISUALLY INSPECTED, AND THE SIEVE CANISTER WAS ALSO REPLACED AS MAINTENANCE IN ACCORDANCE WITH THE REPAIR. SINCE NOISE WAS CONFIRMED BY AN OPERATION CHECK, THE AIR SIDE MANIFOLD WAS REPLACED. CONFIRMED BY AN OPERATIONAL CHECK THAT THE ALARM SOUND AND THE OPERATION SOUND WERE SMALL. THEREFORE, THE ALARM/TILT SENSOR WAS 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: Dyspnea

  MAUDE report 20793201 ↗
• MalfunctionApr 2, 2024Decrease in Pressure; Decrease in Pressure

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF SIMPLYGO MINI AND THE PATIENT ALLEGES THAT THE DEVICE SHOWED AN ERROR CODE E-004 THAT MEANT THAT THERE IS AN ERROR/TECHNICAL PROBLEM IN THE DEVICE PRIMARY ALARM. 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 19020055 ↗
• MalfunctionJan 23, 2024Device Alarm System; Crack; Noise, Audible; Device Alarm System; Crack; Noise, Audible

  A SIMPLYGO MINI DEVICE WAS RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THERE IS NO ALLEGATION OF PATIENT HARM. NO CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS SPECIFIED. DURING THE EVALUATION, THE MANIFOLD AND COMPRESSOR WERE REPLACED DUE TO SIGNIFICANT VIBRATION AND LOUD OPERATING SOUND. THE SIEVE CANISTER WAS REPLACED DUE TO THE ALARM INDICATING, "SIEVE CANISTER NEEDS TO BE CHECKED." THE POWER CONNECTOR WAS REPLACED DUE TO DAMAGE - NO THERMAL DAMAGE OR WIRES WERE EXPOSED. AFTER THE COMPREHENSIVE EXAMINATION, THE UNIT IS OPERATING CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568100 ↗
• MalfunctionOct 2, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE POWER CORD INLET BROKE AND THE POWER CORD FAILED TO BE PUT IN. THERE IS NO REPORT OF EXPOSED CONDUCTING WIRING. THIS ISSUE WOULD NOT INCREASE RISK TO THE INTENDED USER OR CAREGIVER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851049 ↗
• MalfunctionJun 21, 2022Thermal Decomposition of Device; Electrical /Electronic Property Problem; Thermal Decomposition of Device; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLY-GO MINI AC ADAPTOR HAD IGNITED OR SPARKED. THE AC ADAPTOR HAD EVIDENCE OF THERMAL DAMAGE EXPOSING WIRES. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14763240 ↗
• InjuryNov 7, 2021Failure to Deliver; Failure to Deliver

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT'S BLOOD OXYGEN LEVEL WAS 70% AND NOT INCREASING WHEN USING THE SIMPLYGO MINI OXYGEN CONCENTRATOR. THE PATIENT WAS PLACED ON HOSPITAL OXYGEN AND WAS THEN PROVIDED A NEW DEVICE. THE PATIENT'S BLOOD OXYGEN LEVEL RECOVERED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE MANUFACTURER FOUND THE DEVICE TO HAVE A SYSTEM ALARM AND SIEVE ALARM LOGGED. THE COMPRESSOR AND SIEVE CANISTER WERE REPLACED TO ADDRESS THE ISSUE. A LEAK WAS FOUND DURING THE EVALUATION, THE SIEVE O2 ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE IS NOT A LIFE SUSTAINING OR LIFE SUPPORTING. PRODUCT LABELING STATES,"THE OXYGEN DELIVERY SETTINGS OF THE OXYGEN CONCENTRATOR SHOULD BE PERIODICALLY REASSESSED FOR THE EFFECTIVENESS OF THE THERAPY."

  Patient problems: Low Oxygen Saturation

  MAUDE report 12756404 ↗