SimplyGo Mini SimplyGo Mini, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959032385), received between Dec 9, 2021 and Mar 11, 2026 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 7, 2025Open, Classified

   Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

   Z-0481-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Sparking

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A SIMPLYGO MINI DEVICE. THE PATIENT STATED HER DEVICE DOES NOT SEEM TO BE CHARGING, JUST TRIED PLUG THE DEVICE IN AND IT SPARKED. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570979 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION RELATED TO A SIMPLYGO MINI DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING CONGESTIVE HEART FAILURE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 20539525 ↗
• MalfunctionNov 8, 2023Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT'S DEVICE IS NOT TURNING ON OR OFF AND THE DEVICE IS GETTING HOT WHEN IT IS PLUGGED IN TO CHARGE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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 18094323 ↗
• DeathAug 21, 2023Failure to Power Up; Failure to Power Up

  A CONSUMER REPORTED THE PORTABLE OXYGEN CONCENTRATOR WAS NO LONGER FUNCTIONING AFTER 6 WEEKS OF USE. AT THE TIME OF THE INITIAL REPORT, THE PATIENT HAD GONE WITHOUT USE OF THE DEVICE FOR TWO DAYS DUE TO THE DEVICE NOT FUNCTIONING. A MANAGER AT THE STORE WHERE THE DEVICE WAS PURCHASED ALLEGES THE DEVICE WAS DEFECTIVE AND THE MANAGER WOULD NOT EXCHANGE THE DEVICE. DURING AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, AND AN ATTEMPT TO RETRIEVE THE DEVICE, AN ADULT CHILD OF THE PATIENT REPORTED THE PATIENT PASSED AWAY TWO MONTHS AGO. THERE WAS NO MEDICAL INTERVENTION SPECIFIED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE USER MANUAL STATES THE DEVICE IS NOT INTENDED FOR LIFE SUPPORT. WHERE THE PRESCRIBING HEALTH CARE PROFESSIONAL HAS DETERMINED THAT AN INTERRUPTION IN THE SUPPLY OF OXYGEN, FOR ANY REASON, MAY HAVE SERIOUS CONSEQUENCES TO THE USER, AN ALTERNATE SOURCE OF OXYGEN SHOULD BE AVAILABLE FOR IMMEDIATE USE. THE USER MANUAL ALSO STATES THE PHILIPS RESPIRONICS SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR IS FOR PRESCRIPTION USE BY PATIENTS REQUIRING HIGH CONCENTRATIONS OF OXYGEN ON A SUPPLEMENTAL BASIS.

  Patient problems: Insufficient Information; Respiratory Failure

  MAUDE report 17586519 ↗
• MalfunctionDec 9, 2021Low Readings; Temperature Problem; Low Readings; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO MINI OXYGEN CONCENTRATOR HAVE EVIDENCE OF THERMAL DAMAGE TO THE ENCLOSURE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12970926 ↗