SimplyGo SimplyGo, BRRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00606959028838), received between Jul 25, 2024 and Feb 2, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MELTED FILTERS ON A SIMPLYGO DEVICE. 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 24230919 ↗
• MalfunctionJan 22, 2026Melted

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF A SIMPLYGO DEVICE CONFIRMED OF LOW O2, SIEVE CANISTER FAILURE, AND MELTED FILTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147208 ↗
• MalfunctionJan 6, 2026Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE SIMPLYGO DEVICE EXHIBITED LOW O2. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND CONFIRMED THE CUSTOMER¿S COMPLAINT. THE SERVICE TECHNICIAN OBSERVED MELTED FILTER. ADDITIONALLY, THE SERVICE CENTER FOUND DAMAGED MAIN PCA, DAMAGED CANISTER, AND INOPERATIVE COMPRESSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979468 ↗
• MalfunctionDec 26, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE SIMPLYGO DEVICE EXPERIENCED AN EQUIPMENT SOURCE FAILURE, AND THE COMPLAINT WAS CONFIRMED. ADDITIONALLY, FOUND THE MAIN PCA WAS DAMAGED, MELTED FILTER, AND DAMAGED CANISTER. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898641 ↗
• MalfunctionDec 22, 2025Excessive Heating; Excessive Heating

  A DEVICE WAS RETURNED TO A SERVICE CENTER WITH A WORK ORDER REPORTING A SIMPLYGO DEVICE HAS FAULTY EQUIPMENT. UPON EVALUATION OF THE DEVICE, THE CUSTOMERS COMPLAINT WAS CONFIRMED. THE FILTER WAS FOUND TO BE MELTED, PCA DAMAGED, DAMAGED CANISTER AND A LEAK IN THE INTERNAL SPINE WAS FOUND. 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 23863280 ↗
• MalfunctionDec 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER FOR A SIMPLYGO DEVICE. THE TECHNICIAN NOTED MELTED FILER. ADDITIONALLY, THE TECHNICIAN NOTED SIEVE CANISTER FAILURE, AND AN INTERNAL LEAK. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834811 ↗
• MalfunctionDec 17, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE SIMPLYGO DEVICE EXHIBITED MELTED FILTER. ADDITIONALLY, MAIN PCA IS DAMAGED, SIEVE CANISTER IS FAILED, AND PRESSURE VALVE IS DAMAGED. 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 23832072 ↗
• MalfunctionDec 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER FOR A SIMPLYGO MINI DEVICE. THE TECHNICIAN NOTED A DAMAGED MAIN PCA AND CANISTER. ADDITIONALLY, THE TECHNICIAN NOTED MELTED DEVICE FILTER, COMPRESSOR MAKING ABNORMAL NOISE, AND DAMAGED PRESSURE VALVE. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817629 ↗
• MalfunctionNov 18, 2025Melted; Melted

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND BATTER MELTED WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581756 ↗
• MalfunctionNov 15, 2025Overheating of Device; Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A MANUFACTURER'S SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND BATTERY WITH MELTED ELECTRICAL TERMINALS. 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 23563533 ↗
• MalfunctionOct 31, 2025Melted; Melted

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING LOW OXYGEN PURITY, MELTED FILTER AND SIEVE CANISTER FAILURE OCCURRED ON A SIMPLYGO PROFILE. THERE WAS NO DEATH, SERIOUS HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. 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 23440793 ↗
• MalfunctionOct 30, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD-PARTY SERVICE CENTER WORK ORDER FOR A SIMPLYGO DEVICE, WHICH ALLEGED MELTED FILTER. ADDITIONALLY, THE PCA WAS ALSO FOUND TO BE DAMAGED, SIEVE CANISTER WAS FAULTY, AND THE COMPRESSOR WAS MAKING AN ABNORMAL NOISE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425802 ↗
• MalfunctionOct 29, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE SIMPLYGO DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER AND CUSTOMER'S COMPLAINT WAS CONFIRMED. FOUND MELTED FILTER AND SIEVE CANISTER FAILURE. THE DEVICE'S SIEVE CANISTER AND INLET FILTER WERE REPLACED. ADDITIONALLY, THE DEVICE HAS LOW OXYGEN AND REMOVABLE BATTERY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411394 ↗
• MalfunctionOct 28, 2025Melted; Melted

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE SIMPLY GO DEVICE EXHIBITED MELTED FILTER, NO POWER, DAMAGED PCA, FAILED SIEVE CANISTER AND DAMAGED PRESSURE VALVE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407701 ↗
• MalfunctionOct 27, 2025Melted; Melted

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLYGO DEVICE. THERE WAS AN ALLEGATION OF DEVICE ALARMING. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING EVALUATION, THE CUSTOMER COMPLAINT WAS CONFIRMED. MOREOVER, MELTED FILTER, PCA ERROR AND SIEVE CANISTER FAILURE WAS FOUND. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390862 ↗
• MalfunctionAug 28, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER FOR A SIMLYGO DEVICE DUE TO ALARMING AND THE COMPLAINT WAS CONFIRMED. THE THIRD- PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND MELTED FILTER. IN ADDITION, SERVICE CENTER ALSO FOUND SIEVE CANISTER FAILURE. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22916460 ↗
• MalfunctionAug 28, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER FOR A SIMLYGO DEVICE DUE TO NO POWER AND THE COMPLAINT WAS CONFIRMED. THE THIRD- PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND MELTED FILTER. IN ADDITION, SERVICE CENTER ALSO FOUND SIEVE CANISTER FAILURE AND LOW O2. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22916305 ↗
• MalfunctionAug 27, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLY GO DEVICE. THE DEVICE WAS RETURNED TO THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE EVALUATION RESULT FOUND THAT THE FILTER WAS MELTED, AND THE COMPLAINT WAS CONFIRMED. THERE WERE ALSO ADDITIONAL FINDINGS OF SIEVE CANISTER FAILURE, DAMAGED PRESSURE VALVE, LEAK INTERNAL SPINE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. ALTHOUGH THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, THIS COMPLAINT IS REPORTABLE BECAUSE THE REPORTED ISSUE/EVENT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22909228 ↗
• MalfunctionAug 27, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER FOR A SIMLYGO DEVICE DUE TO NO POWER AND THE COMPLAINT WAS CONFIRMED. THE THIRD- PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND MELTED FILTER. IN ADDITION, SERVICE CENTER ALSO FOUND SIEVE CANISTER FAILURE AND PCA ERROR. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22907746 ↗
• MalfunctionAug 27, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. AS PER WORK WORD EVALUATION RESULT STATED THAT THE COMPLAINT WAS CONFIRMED AND FOUND MELTED FILTER DURING EVALUATION. ALTHOUGH THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, THIS COMPLAINT IS REPORTABLE BECAUSE THE REPORTED ISSUE/EVENT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907634 ↗
• MalfunctionAug 27, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE SIMPLYGO DEVICE WAS RETURNED TO A SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND DEVICE HAS MELTED FILTER. ADDITIONALLY, THE COMPLAINT WAS CONFIRMED FOR NO POWER, FOUND SIEVE CANISTER FAILURE AND DAMAGED MAIN PCA. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22905345 ↗
• MalfunctionAug 26, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER FOR A SIMLYGO DEVICE DUE TO NO POWER AND THE COMPLAINT WAS CONFIRMED. THE THIRD- PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND MELTED FILTER. IN ADDITION, SERVICE CENTER ALSO FOUND SIEVE CANISTER FAILURE AND DAMAGE MAIN PCA. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22900378 ↗
• MalfunctionMay 30, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE'S THERMAL EVENT. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE DEVICE HAS ¿MELTED FILTER¿. ADDITIONALLY, THE COMPLAINT WAS CONFIRMED FOR ALARMING, NO POWER, FOUND SIEVE CANISTER FAILURE AND DAMAGED MAIN PCA. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THE PATIENT REQUIRED NO MEDICAL INTERVENTION. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED, AND 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 22118302 ↗
• MalfunctionDec 10, 2024Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING BATTERIES WERE MELTED. 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 20893067 ↗
• MalfunctionDec 10, 2024Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MELTED BATTERY IN A SIMPLYGO DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF SMOKE OR FIRE. 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 20892322 ↗