SimplyGo Mini SimplyGo Mini with Standard Battery, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00606959032422), received between Feb 5, 2024 and Dec 3, 2025 — classified as 1 death, 11 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Overheating of Device; Overheating of Device

  THE SIMPLYGO MINI WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION WITHOUT AN INITIAL CUSTOMER COMPLAINT. DURING THE EVALUATION IT WAS NOTED THAT THE MAIN PRINTED CIRCUIT ASSEMBLY HAD THERMAL DAMAGE. ADDITIONALLY, A TECH FAULT WAS REPORTED, THE REAR COVER WAS FOUND CRACKED, THE O2 SIDE ASSEMBLY AND AIRSIDE ASSEMBLY WERE FOUND CONTAMINATED THEREFORE THEY WERE REPLACED. IN CONCLUSION, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709293 ↗
• MalfunctionNov 19, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN INITIAL ALLEGATION OF WON¿T TURN ON. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS INSPECTED, AND THE TECHNICIAN NOTICED THAT THE PCA IS BURNT. ADDITIONALLY, THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS. THE DEVICE WILL BE RETURNED TO THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591745 ↗
• MalfunctionNov 17, 2025Sparking; Sparking

  THE MANUFACTURER RECEIVED INFORMATION ON A SIMPLYGO MINI DEVICE ALLEGING "SPARKS BETWEEN THE DEVICE AND SOCKET." THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577808 ↗
• MalfunctionNov 14, 2025Thermal Decomposition of Device; Overheating of Device; Thermal Decomposition of Device; Overheating of Device

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND PCA IS BURNED, FRONT AND REAR COVER ARE BURNED. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555046 ↗
• MalfunctionSep 10, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A COMPLAINT ALLEGING THAT THE SIMPLYGO MINI DEVICE HAD NO BATTERY CHARGE. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE'S MAIN PCA WAS BURNED. ADDITIONALLY, DURING THE EVALUATION OF THE DEVICE, THE FIELD SERVICE ENGINEER OBSERVED THAT THE SIEVES WERE CLOGGED, THE COMPRESSOR WAS CONTAMINATED, AND THE AIR SIDE & O2 SIDE WERE DEFECTIVE. THE DEVICE WILL BE RETURNED UNREPAIRED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB FOR FURTHER INVESTIGATION. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023074 ↗
• MalfunctionAug 1, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION IT HAS BEEN OBSERVED THAT THE DEVICE DIDN'T TURN ON. ONCE THE DEVICE WAS OPENED A BURNT ATTACHMENT WAS FOUND ON THE BACK OF THE MAIN PCA THEREFORE THAT WAS REPLACED. A NEW ESD SHIELD WAS ADDED AS IT HAD BURN MARKS SO, IT WAS REPLACED AS A PRECAUTION. THE REAR COVER WAS REPLACED AS IT HAD LOOSE CONNECTIONS TO THE DEVICE. THE AIRSIDE MANIFOLD ASSEMBLY WAS REPLACED. SIEVES AND INLET FILTERS WERE REPAIRS AS PER SERVICE MANUAL. ALL TESTS PASSED AND SERVICE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685499 ↗
• MalfunctionJul 14, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR. THE CUSTOMER ALLEGED KEYBOARD. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE. DURING THE EVALUATION, THE SERVICE TECHNICIAN REPORTS FINDING SIEVES ARE CLOGGED, THE PCA IS BURNED, THE INLET FILTER NEED TO BE REPLACED. THE DEVICE WAS NOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495133 ↗
• MalfunctionJan 21, 2025Circuit Failure; Display or Visual Feedback Problem; Gas Output Problem; Temperature Problem; Insufficient Device Problem Information; Circuit Failure; Display or Visual Feedback Problem; Gas Output Problem; Temperature Problem; Insufficient Device Problem Information

  THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND MAIN PCA IS BURNT. ADDITIONALLY, SIEVES ARE CLOGGED, DISPLAY IS DAMAGE AND NON-OPERATIONAL, AIR SIDE AND O2 SIDE ARE LEAKING, INLET FILTERS NEED TO BE CHANGED DUE TO PREVENTIVE MAINTENANCE. THE CUSTOMER COMPLAINT WAS REPRODUCED. THE CUSTOMER COMPLAINT WAS REPRODUCED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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 21201022 ↗
• MalfunctionJan 3, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MIN. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED FINDINGS LIKE PCA BURNED DURING THE EVALUATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071778 ↗
• MalfunctionJan 1, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  AN OXYGEN CONCENTRATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REPAIRS OF A PRODUCT MALFUNCTION. THE PATIENT REPORTED ALLEGATIONS OF A BURNING SMELL COMING FROM THE DEVICE. THERE WERE NO ALLEGATIONS OF HARM OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT SPECIFIED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF A BURNT PCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21050951 ↗
• DeathMay 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A DEATH INVOLVING A PHILIPS DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE OXYGEN- DEPENDENT PATIENT ARRIVED AT THE HOSPITAL ON THURSDAY, (B)(6), AND BROUGHT HIS PORTABLE TANK FROM ANOTHER PROVIDER, OXYVIE. UPON THE PATIENT'S ARRIVAL, THE HOSPITAL SET UP A DIFFERENT CONCENTRATOR. THE PATIENT REPORTEDLY HAS LUNG CANCER AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND IS REPORTED TO BE ON 2-4 LITERS OF OXYGEN ON THE OXYVIE PORTABLE CONCENTRATOR. THE HOSPITAL HAD A POWER OUTAGE DUE TO BAD WEATHER AND THE CONCENTRATOR STOPPED WORKING. THE PATIENT CALLED THE INFIRMARY TO REPORT THE CONCENTRATOR WAS RINGING BECAUSE THERE WAS NO POWER AND WAS SWITCHED TO A PHILIPS SIMPLY GO. AFTER A WHILE THE NURSE FOUND THE PATIENT AT REST, THE PORTABLE CONCENTRATOR WAS NOT SWITCHED ON, WHICH RESULTED IN THE PATIENT'S DEATH. NO FURTHER DETAILS WERE PROVIDED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 19425724 ↗
• MalfunctionFeb 5, 2024Inaccurate Flow Rate; Intermittent Loss of Power; Inaccurate Flow Rate; Intermittent Loss of Power

  A SIMPLYGO MINI WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR REPAIR. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE DEVICE LOSES POWER BY ITSELF AND HAS LOW O2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646497 ↗