SimplyGo Mini SimplyGo Mini, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959032415), received between Jan 23, 2024 and Oct 15, 2025 — classified as 4 malfunctions.

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

• MalfunctionOct 15, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SIMPLYGO MINI DEVICE HAD A LOW OXYGEN CONCENTRATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE HAD A BURNED PCA. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB FOR ADDITIONAL TESTING. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279314 ↗
• MalfunctionSep 9, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SIMPLYGO MINI DEVICE WOULD NOT CHARGE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE PHILIPS SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE HAD A BURNT MAIN PCA. IN CONCLUSION, THE DEVICE'S PCA WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE INLET FILTERS WERE REPLACED, THE SIEVES WERE REPLACED, THE AIR SIDE ASSEMBLY WAS NOISY AND REPLACED, AND THE O2 SIDE ASSEMBLY WAS REPLACED. THESE WERE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007302 ↗
• MalfunctionJan 1, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE WERE SOME SECONDARY FINDINGS LIKE SIEVES ARE CLOGGED, AIR SIDE & O2 SIDE & THE COMPRESSOR ARE DEFECTIVE, PCA IS BURNT. 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 21051813 ↗
• MalfunctionJan 23, 2024Power Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI WITH A COMPLAINT OF THE PLUG ATTACHMENT WAS BROKEN. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, SIEVES WERE CLOGGED, AIR SIDE AND O2 SIDE AND THE COMPRESSOR WAS DEFECTIVE, AND THE POWER CONNECTOR WAS CRACKED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566802 ↗