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

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00606959032408), received between Jan 5, 2017 and Jun 19, 2025 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF SIMPLYGO MINI DEVICE WITH ALLEGED PCA-BURNT CIRCUITRY AND THAT THE DEVICE IS NOT POWERING UP. A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THEY FOUND OUT BLACK RESIDUE IN THE TUBING, REAR COVER AND POWER CONNECTOR ARE BURNT. SIEVES COMPACTED, THE AIR SIDE IS BLACKEND AND THE O2 SIDE CRACKED. THE DEVICE FAULTY PARTS HAVE BEEN REPLACED. REPORTABLE SINCE DEVICE ISSUE/EVENT HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289287 ↗
• MalfunctionMay 19, 2025Corroded; No Apparent Adverse Event; Corroded; No Apparent Adverse Event

  AS PER WORK ORDER:RECEIVED 4/22: BLACK RESIDUE IN TUBING. AIR SIDE-BLACKEND. 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 22044508 ↗
• MalfunctionMay 19, 2025Corroded; No Apparent Adverse Event; Corroded; No Apparent Adverse Event

  AS PER WORK ORDER: RECEIVED 4/22: BLACK RESIDUE IN TUBING AIR SIDE-BLACKENED. 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 22044507 ↗
• MalfunctionApr 22, 2025Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING PCA BURNT. 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 21879108 ↗
• MalfunctionJan 29, 2025Degraded; Degraded

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMLYGO MINI OXYGEN CONCENTRATOR DUE TO THE SIEVE WAS FOUND SATURATED, , THE POWER CONNECTOR WAS CRACKED, THE FILTER WAS DIRTY, AND THE SHIPPING CARTON SG MINI WAS MISSING. 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 21268046 ↗
• MalfunctionOct 16, 2024Thermal Decomposition of Device; No Apparent Adverse Event; Thermal Decomposition of Device; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMPLY GO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO PCA-TECHNICAL FAULT AND VERY LOW OXYGEN, THE COMPRESSOR HAD BLACK RESIDUE IN THE TUBING, THE SIEVES WERE COMPACTED, THE AIR SIDE WAS BLACKENED AND CHIRPING, AND THE OXYGEN SIDE WAS CRACKED. THE FAULTY PARTS WERE REPLACED. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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 20461751 ↗
• MalfunctionOct 16, 2024Thermal Decomposition of Device; Gas/Air Leak; No Apparent Adverse Event; Thermal Decomposition of Device; Gas/Air Leak; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO PCA-TECHNICAL FAULT AND VERY LOW OXYGEN, THE COMPRESSOR HAD BLACK RESIDUE IN THE TUBING, THE SIEVES WERE COMPACTED, THE AIR SIDE WAS BLACKENED AND CHIRPING, AND THE OXYGEN SIDE WAS LEAKING. THE FAULTY PARTS WERE REPLACED. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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 20461367 ↗
• MalfunctionAug 23, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER BECAME AWARE THAT A USER OF THE SIMPLYGO MINI HAD STATES DAMAGE TO THE PC BOARD DUE TO OVERHEATING/ELECTRICAL BURN. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. 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 20056605 ↗
• MalfunctionAug 5, 2024Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A SIMPLYGO MINI DEVICE ALLEGING BLACK RESIDUE. THE DOCTOR PRESCRIBED ANTIBIOTIC AND ANTI-ALLERGIC MEDICINES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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 19911521 ↗
• MalfunctionJul 17, 2024Gas/Air Leak; Gas/Air Leak

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO A DIAGNOSTIC TEST PERFORMED; POWER CONNECTOR BROKEN; CHECK VALVES LEAKING; BED ALARM. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE PARTS WERE REPLACED, AND THE MACHINE WAS CALIBRATED. THIS REPORT IS BEING SUBMITTED DUE TO THE CHECK VALVES LEAKING. 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 19761834 ↗
• MalfunctionJun 7, 2024Material Discolored; Material Discolored

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR ROUTINE MAINTENANCE. DURING THE ROUTINE MAINTENANCE DEVICE MALFUNCTION WERE REPAIRED. THE MAINTENANCE REPORT INDICATED BLACK RESIDUE IN TUBING, BLACKENED AIR SIDE. THERE IS NO ALLEGATION OF HARM OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489763 ↗
• MalfunctionJun 7, 2024Material Discolored; Material Discolored

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR ROUTINE MAINTENANCE. DURING THE ROUTINE MAINTENANCE DEVICE MALFUNCTION WERE REPAIRED. THE MAINTENANCE REPORT INDICATED BLACK RESIDUE IN TUBING, BLACKENED AIR SIDE. THERE IS NO ALLEGATION OF HARM OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489323 ↗
• MalfunctionJun 7, 2024Material Discolored; Material Discolored

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR ROUTINE MAINTENANCE. DURING THE ROUTINE MAINTENANCE DEVICE MALFUNCTION WERE REPAIRED. THE MAINTENANCE REPORT INDICATED BLACK RESIDUE IN TUBING, BLACKENED AIR SIDE. THERE IS NO ALLEGATION OF HARM OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488779 ↗
• MalfunctionJun 7, 2024Material Discolored; Material Discolored

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR ROUTINE MAINTENANCE. DURING THE ROUTINE MAINTENANCE DEVICE MALFUNCTION WERE REPAIRED. THE MAINTENANCE REPORT INDICATED BLACK RESIDUE IN TUBING, BLACKENED AIR SIDE. THERE IS NO ALLEGATION OF HARM OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483625 ↗
• MalfunctionApr 25, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR. THE DEVICE WAS EVALUATED BY A SERVICE TECHNICIAN. THE TECHNICIAN REPORTS FINDING A BURNED POWER CORD, SIEVE BEDS LOW OXYGEN, MANIFOLD ASSEMBLY SQUEAKS AND CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182880 ↗
• MalfunctionApr 8, 2024Crack; Insufficient Flow or Under Infusion; Noise, Audible; Crack; Insufficient Flow or Under Infusion; Noise, Audible

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLYGO MINI DEVICE. THE DEVICE WAS INSPECTED AND ANALYZED BY A FASC REPRESENTATIVE, AND THE COMPLAINT WAS CONFIRMED: SIEVE BED WITH LOW )2, )2 SIDE CHECK VALVES MALFUNCTIONING, AIRSIDE MANIFOLD CHIRPING, THE POWER CONNECTOR WAS BROKEN, COMPRESSOR LEAD WIRE DAMAGE AND THE MAIN PCA BOARD HAD LOW FLOW. THE DEVICE'S SOFTWARE WAS ALSO UPGRADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057198 ↗
• MalfunctionFeb 11, 2024Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, IT WAS CONFIRMED THAT THE SIEVE BEDS HAD LOW O2, THE FRONT ENCLOSURE CRACKED, O2 SIDE CHECK VALVES WERE MALFUNCTIONING, AIRSIDE MANIFOLD CHIRPING, INLET FILTERS NEED PREVENTATIVE MAINTENANCE, TUBING NEEDED PREVENTATIVE MAINTENANCE, THE MAIN PCS DAS LOW FLOW, AND THE COMPRESSOR HAS LEAD WIRE DAMAGE. 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 18682774 ↗
• MalfunctionJan 24, 2024Crack; Gas Output Problem; Mechanical Problem; Noise, Audible; Crack; Gas Output Problem; Mechanical Problem; Noise, Audible

  A SIMPLYGO MINI OXYGEN CONCENTRATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR INSPECTION/EVALUATION. THERE ARE NO ALLEGATIONS OF SERIOUS INJURY OR HARM, AND NEITHER IS MEDICAL INTERVENTION SPECIFIED. THE COMPLAINT OF THE CHARGE PORT BEING BROKEN WAS CONFIRMED. DURING THE EVALUATION, THE SIEVE BEDS HAD LOW O2, MALFUNCTIONING VALVES, AIRSIDE MANIFOLD CHIRPING, THE POWER CONNECTOR BROKEN, THE COMPRESSOR HAD LEAD WIRE DAMAGE, AND THE MAIN PCA BOARD HAD LOW FLOW. AFTER THE COMPREHENSIVE EVALUATION, THE NECESSARY PARTS WERE REPLACED, AND THE SOFTWARE WAS UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572192 ↗
• MalfunctionJan 22, 2024Power Problem; Power Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCES TO MALFUNCTIONS OF A SIMPLYGO MINI DURING ROUTINE MAINTENANCE OF THE DEVICE. IT WAS REPORTED IN THE MAINTENANCE REPORT DAMAGED POWER CORD. 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 18560349 ↗
• MalfunctionJan 10, 2024Fracture; Device Damaged Prior to Receipt by User; Noise, Audible; Fracture; Device Damaged Prior to Receipt by User; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI DEVICE. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED SIEVE BEDS HAD LOW O2, THE MANIFOLD ASSEMBLY SQUEAKS, THE MANIFOLD ASSEMBLY WAS CRACKED, THE POWER CONNECTOR WAS DAMAGED, AND THE SHIPPING BOX WAS DAMAGED. 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 18489922 ↗
• MalfunctionDec 28, 2023Contamination; Defective Component; Contamination; Defective Component

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS SERVICED BY A FIELD SERVICE TECHNICIAN. DURING THE EVALUATION OF THE DEVICE HAD HIGH PRESSURE SIEVE CANISTER ASSEMBLY, DEFECTIVE PCA, CONTAMINATED INLET FILTER, DIRTY PATIENT FILTER AND RED LIGHT ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415090 ↗
• MalfunctionDec 22, 2023Vibration; Insufficient Flow or Under Infusion; Tear, Rip or Hole in Device Packaging; Noise, Audible; Vibration; Insufficient Flow or Under Infusion; Tear, Rip or Hole in Device Packaging; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. A REPAIR WORK ORDER AND INVOICE WAS RECEIVED FROM THE THIRD PARTY SERVICE CENTER THAT MENTIONED THE DEVICE'S SIEVE BEDS CONTAINED LOW O2, THE MOTOR WAS NOISY AND VIBRATING, THE MANIFOLD ASSEMBLY WAS CRACKED, AND THE POWER CONNECTOR WAS DAMAGED. THE UNIT WOULD NOT START AND IT WAS ALSO MENTIONED THAT THE SHIPPING BOX WAS DAMAGED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR 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 18381712 ↗
• MalfunctionDec 20, 2023Corroded; Corroded

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN. THE SERVICE TECHNICIAN REPORTS THE BATTERY PCA CORRODED, FAULTY MAIN PCA CAUSING NO CHARGE, AND AIRSIDE MANIFOLD SQUEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369233 ↗
• MalfunctionDec 19, 2023Crack; Insufficient Flow or Under Infusion; Material Deformation; Crack; Insufficient Flow or Under Infusion; Material Deformation

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS EVALUATED BY A SERVICE TECHNICIAN. THE TECHNICIAN REPORTS THAT THE DEVICE HAS LOW OXYGEN, MANIFOLD ASSEMBLY LEAK, CRACKED, BURN DAMAGE, AND SHIPPING BOX DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360097 ↗
• MalfunctionDec 1, 2023Contamination; Crack; Contamination; Crack

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS SERVICED BY A FIELD SERVICE TECHNICIAN. THE TECHNICIAN EVALUATED THE DEVICE AND ALLEGED BLACK RESIDUE IN TUBING, SIEVE COMPACTED, AIR SIDE BLACKENED AND O2 SIDE CRACKED. THE FAULTY PARTS WERE REPLACED. 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 18251688 ↗