SimplyGo Mini SimplyGo Mini with Extended Battery, IKKRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959033832), received between Apr 25, 2024 and May 27, 2026 — classified as 4 malfunctions.

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

• MalfunctionMay 27, 2026Overheating of Device

  A SIMPLYGO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER COMPLAINT WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT THE PCA WAS BURNED AND REQUIRED REPLACEMENT. 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 25301050 ↗
• MalfunctionApr 30, 2026Overheating of Device

  A SIMPLYGO MINI DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED A THERMAL EVENT WITH BURN MARKS AND BURNT PCA. THE DEVICE WILL BE RETURNED TO THE PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049942 ↗
• MalfunctionJul 14, 2025Excessive Heating; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION ON A SIMPLYGO MINI DEVICE. ACCORDING TO CUSTOMER, THE DEVICE INDICATED OVERHEATING. THE DEVICE HAS BEEN RETRIEVED FROM THE PATIENT. DURING EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF BURNT PCA. MAIN PCA, CLOGGED, SIEVES, AND DEFECTIVE O2 SIDE WAS REPLACED THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS REPAIRED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496569 ↗
• MalfunctionApr 25, 2024Thermal 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 19178047 ↗