SimplyGo SimplyGo, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00606959020801), received between May 12, 2021 and Sep 3, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (10 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Melted

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598361 ↗
• MalfunctionJun 2, 2026Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION WITH ALLEGATIONS THAT THE LIGHT WON'T TURN ON ANYMORE. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT THE UNIT HAD COME WITH THE LIGHT WON'T TURN ON ANYMORE BECAUSE THE PCA WAS BURNED. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED SIEVES WERE CLOGGED, INLET FILTER NEEDS TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE, CHECK VALVE WAS CRACKED, CABLE TIES NEED REPLACEMENT, FLEXCABLE AND FRONT ENCLOSURE ARE BURNED. THESE PARTS NEED REPLACEMENT. THE DEVICE WAS REPAIRED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366108 ↗
• MalfunctionMar 19, 2026Thermal Decomposition of Device

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE SIMPLYGO DEVICE. THERE WAS A REPORT OF COMPRESSOR NO LONGER STARTS. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT SIEVES WERE CLOGGED, PCA BURNT AND INLET FILTER WAS REPLACED DUE TO PREVENTIVE MAINTENANCE. THE DEVICE WAS REQUESTED TO BE SENT TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB (PIL) FOR FURTHER INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641054 ↗
• MalfunctionMar 13, 2026Overheating of Device; Failure to Power Up

  A SIMPLYGO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE WITH AN ALLEGATION OF THE DEVICE WON'T TURN ON. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE'S PRINTED CIRCUIT BOARD WAS BURNED, THE UNIT COULD NOT BE TURNED ON, SIEVES WERE CLOGGED, AND FLEX CABLE HAD BURNED MARKS. THERE IS NO INFORMATION AVAILABLE ABOUT THE HOURS, FIRMWARE AND SOFTWARE OF THE DEVICE. THE INLET FILTER WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE. IN CONCLUSION, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY AND FRONT ENCLOSURE WILL NEED TO BE REPLACED. THE INVESTIGATION IS ONGOING. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER SERVICE CENTER FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599445 ↗
• MalfunctionFeb 26, 2026Thermal Decomposition of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN INITIAL ALLEGATION OF THE DEVICE SHOWING A POWER ISSUE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEBUG TECHNICIAN NOTICED THAT THE PCA IS BURNT AND THE RP-SIMLY GO PCA NEEDS TO BE CHANGED. ADDITIONALLY, THE DEVICE WAS RETURNED TO THE PIL FOR FURTHER INVESTIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465050 ↗
• MalfunctionDec 2, 2025Overheating of Device; Overheating of Device

  THE SIMPLYGO DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND PCA IS BURNT. 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 23697111 ↗
• MalfunctionNov 26, 2025Excessive Heating; Excessive Heating

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND BURNED PCA (COULD NOT READ HOURS), SIEVES ARE CLOGGED, INLET FILTER WILL BE REPLACED DUE TO PREVENTATIVE MAINTENANCE. 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 23657895 ↗
• MalfunctionNov 14, 2025Fire; Fire

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A SIMPLYGO DEVICE INVOLVING FIRE. THERE WAS NO INITIAL REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM A GFE ATTEMPT VIA EMAIL STATES, "THE PATIENT HAD USED THE PORTABLE OXYGEN CONCENTRATOR DURING A 3-HOUR CONSULTATION ON (B)(6) 2024. UPON RETURNING HOME, THEY PLUGGED IN THE DEVICE TO CHARGE. ABOUT AN HOUR LATER, THE EQUIPMENT CAUGHT FIRE. THE PATIENT WAS USING THE POC PLUGGED INTO THE POWER OUTLET WHEN THE INCIDENT OCCURRED. AFTER VITALAIRE'S VISIT TO THE PATIENT, IT WAS CLARIFIED THAT THE FIRE WAS LIMITED TO THE CONSUMABLES (EXTENSION/CANNULA), NOT THE CONCENTRATOR ITSELF. THE POSSIBLE PRIMARY CAUSE WAS IDENTIFIED AS THE PATIENT SMOKING WHILE USING THE POC. " DAMAGE REPORTED WAS DESCRIBED AS OCCURRING ONLY IN THE CONSUMABLES (EXTENSION/CANNULA). SPECIFICALLY, THERE WAS ONE END OF THE EXTENSION OR CANNULA THAT WAS BURNED AND MELTED. THE DEVICE ITSELF WAS NOT DAMAGED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, HAS BEEN SENT TO THE MANUFACTURER FOR ANALYSIS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559860 ↗
• MalfunctionNov 10, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLY GO DEVICE STARTS AND SWITCHES ITSELF ON AND OFF. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND THE PCA BURNT. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23517155 ↗
• MalfunctionOct 27, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO DEVICE WITH A CUSTOMER ALLEGATION OF DEVICE NOT WORKING. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED THAT THE PCA WAS BURNT, AND IT NEEDED TO BE CHANGED. THE DEVICE WILL BE SENT TO PIL FOR FURTHER INVESTIGATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390015 ↗
• MalfunctionOct 15, 2025Excessive Heating; Excessive Heating

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNT PCA. 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 23303711 ↗
• MalfunctionSep 15, 2025Melted; Melted

  A SIMPLYGO DEVICE WAS RETURNED TO A MANUFACTURER SERVICE CENTER FOR SERVICE WITH THE ALLEGATION OXYGEN CONCENTRATION IS LOW. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT SERVICE CENTER, THE SERVICE OBSERVED THAT CONNECTION BETWEEN THE INLET FILTER AND THE INLET HOSE IS MELTED AND CLOGGED IN THE DEVICE. THE DEVICE'S SIEVE CANISTER KIT, SIMPLYGO INLET FILTER KIT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059343 ↗
• MalfunctionSep 15, 2025Melted; Melted

  A SIMPLYGO DEVICE WAS RETURNED TO MANUFACTURER SERVICE CENTER FOR SERVICE WITH ALLEGATION OF BATTERY NOT CHARGING. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT MANUFACTURER SERVICE CENTER, THE SERVICE OBSERVED INLET FILTER AND THE INLET HOSE IS MELTED AND CLOGGED IN THE DEVICE. THE DEVICE'S BATTERY CONNECTION PCA, SIEVE CANISTER KIT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059342 ↗
• MalfunctionSep 11, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO DEVICE HAD A POWER CONNECTION PROBLEM AND THE CIRCUIT BOARD WAS DEFECTIVE. 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¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE PCA WAS BURNED BEHIND THE AC POWER CONNECTOR. IN ADDITION, THE UNIT STARTS WITH A BATTERY AS A POWER SOURCE, THE SIEVE CANISTERS WERE WORN OUT, THE TUBING WAS CONTAMINATED, AND THE INLET FILTER NEEDED TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE. THE DEVICE WILL BE RETURNED TO THE PIL FOR ADDITIONAL TESTING. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME. 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 23032482 ↗
• MalfunctionSep 10, 2025Overheating of Device; Overheating of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD-PARTY 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, SEVERAL ISSUES WERE FOUND: THE SIEVES WERE CLOGGED, THE EXHAUST MUFFLER WAS DAMAGED, AND THE FRONT ENCLOSURE REQUIRED REPLACEMENT BECAUSE OF ITS BURNT DISPLAY AND FAULTY POWER CONNECTOR. THE INLET FILTER WAS ALSO REPLACED FOR PREVENTIVE MAINTENANCE. 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 23015083 ↗
• MalfunctionAug 24, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A SIMPLY GO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH AN INITIAL COMPLAINT OF TOO LITTLE O2, THE UNIT IS NOISY, AND NEEDS MAINTENANCE. NO SERIOUS HARM OR INJURY WAS REPORTED. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN NOTED THAT THE PCA WAS BURNT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED SIEVES ARE CLOGGED AND INLET FILTER NEEDS REPLACING DUE TO PREVENTIVE MAINTENANCE. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. 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 22881405 ↗
• MalfunctionAug 4, 2025Device Emits Odor; Device Emits Odor

  THE MANUFACTURER RECEIVED INFORMATION ON A SIMPLY GO DEVICE ALLEGING BAD BURNING SMELL COMING OUT OF THE DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED AS REQUIRED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE, AT THE MANUFACTURE'S SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF THERMAL DAMAGE ON THE PCA INSIDE ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709235 ↗
• MalfunctionJul 30, 2025Device Emits Odor; Device Emits Odor

  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. THE UNIT DOSE NOT STARTED. DURING THE EVALUATION OF THE DEVICE, THEY FOUND PCA IS BURNED. SIEVES ARE CLOGGED. INLET FILTER NEEDS TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668644 ↗
• MalfunctionJul 14, 2025Device Emits Odor; Device Emits Odor

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF SIMPLYGO DEVICE THAT THE PATIENT ALLEGES THAT THE DEVICE SWITCHES OFF AND ON AFTER A FEW SECONDS DESPITE THE POWER SUPPLY BEING PLUGGED IN. IN ADDITION THE PATIENT ALLEGES THAT THE DEVICE IS PRODUCING A BURNING SMELL. 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 22491406 ↗
• MalfunctionMar 31, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE DEVICE SIMPLYGO. THE DEVICE WAS RETURNED TO THE MANUFACTURER AUTHORIZED SERVICE CENTER AND EVALUATION RESULT FOUND BURNT PCA. PCA, INLET FILTER SIEVE, COMPRESSOR WAS REPLACED 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 21730358 ↗
• InjuryJan 28, 2025Backflow; Inaccurate Delivery; Unexpected Shutdown; Backflow; Inaccurate Delivery; Unexpected Shutdown

  THE MANUFACTURER HAS BEEN INFORMED THAT A USER OF A SIMPLYGO PORTABLE OXYGEN CONCENTRATOR HAS BEEN HOSPITALIZED TWICE WHILE USING THE DEVICE. THE UNIT OPERATES ON A 4.5 PULSE FLOW AND SHUTS OFF AFTER 13 MINUTES OF USE, RENDERING IT UNRELIABLE. THE CUSTOMER IS REQUESTING A REPLACEMENT CONCENTRATOR. THE USER REPORTED INCIDENTS OCCURRING IN (B)(6) 2024, (B)(6) 2024, AND (B)(6) 2025. THE USER FOLLOWS A MAINTENANCE ROUTINE OF CLEANING THE DEVICE WEEKLY WITH DAMP CLOTH AND REPLACING THE CANNULA MONTHLY. ACCORDING TO THE USER, THE ALARMS DID NOT FUNCTION PROPERLY ACROSS VARIOUS SETTINGS. ON THE DAY OF RETRIEVAL FOLLOWING REPAIR, THE UNIT OPERATED FOR 13 MINUTES ON SETTING 5 (PULSE), THEN ALARMED, SHUT OFF, AND CYCLED ON AND OFF WHILE ALARMING AT 3-MINUTE AND 1-MINUTE INTERVALS. ON ANOTHER OCCASION, THE MALFUNCTION ALARM TRIGGERED ON MULTIPLE SETTINGS, RENDERING THE DEVICE UNUSABLE. DUE TO THESE ONGOING ISSUES, THE PATIENT WAS HOSPITALIZED UNTIL AN ALTERNATIVE OXYGEN CONCENTRATOR COULD BE ARRANGED AT THE PATIENT'S EXPENSE. GIVEN THE PERSISTENT MALFUNCTIONS AND ASSOCIATED COSTS, THE PATIENT IS REQUESTING A FULL REFUND. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE

  Patient problems: Insufficient Information

  MAUDE report 21256699 ↗
• MalfunctionSep 23, 2024Thermal Decomposition of Device; Excessive Heating; Thermal Decomposition of Device; Excessive Heating

  THE DEVICE POWER SUPPLY WAS FOUND TO HAVE SCORCH MARKS ON RIBBON CABLE. THE DEVICE WAS UNREPAIRABLE. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, THIS EVENT IS REPORTABLE DUE TO A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. A REPORT WILL BE FILED WITH ALL APPLICABLE REGULATORY AGENCIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287867 ↗
• MalfunctionAug 13, 2024Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF SIMPLYGO STATING THAT THE DEVICE HAS A CLOGGED SIEV, COMPRESSOR DOES NOT WORK IN NORMAL PARAMETERS. PCA IS DEFECTIVE AND HAS BURNT COMPONENTS. 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 19978598 ↗
• MalfunctionMay 16, 2024Unexpected Shutdown; Excessive Heating; Unexpected Shutdown; Excessive Heating

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER ALLEGING THE DEVICE WOULD TURN OFF. DURING EVALUATION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE THERMAL DAMAGE TO THE PCA (PRINTED CIRCUIT ASSEMBLY). THE PCA WAS BURNED AND IN NEED OF REPLACEMENT. THE DEVICE WAS ALSO FOUND TO HAVE LOW OXYGEN, AND THE SIEVES WERE DEFECTIVE AND NEEDED REPLACEMENT. THE TUBING KIT WAS CONTAMINATED. THE COMPRESSOR WAS IN NEED OF REPLACEMENT, AND THE INLET FILTER WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE DEVICE WAS REPAIRED AND PASSED A PERFORMANCE TEST. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329034 ↗
• InjuryMar 5, 2024Failure to Charge; Unexpected Shutdown; Failure to Charge; Unexpected Shutdown

  THE MANUFACTURER WAS CONTACTED IN REFERENCES TO A MALFUNCTION OF A SIMPLYGO OXYGEN CONCENTRATOR. THE MANUFACTURER RECEIVED INFORMATION STATING THE DEVICE IS NOT CHARGING AND THE UNIT IS TURNING OFF DURING USE. THE PATIENT STATED THE DEVICE WILL ONLY WORK FOR 2 HOURS AT A TIME AND THERE ARE NO ERROR MESSAGES ON THE DEVICE WHILE IN USE. THE PATIENT ALLEGES BREATHING ISSUES AND LOW OXYGEN. THE PATIENT ALSO STATED HE WAS HOSPITALIZED FOR THE BREATHING ISSUES AND LOW OXYGEN AND WAS PLACED ON 4 LITERS OF OXYGEN AND WAS GIVEN MEDICATION FOR HIS HEART AND LUNGS.

  Patient problems: Dyspnea; Hypoxia

  MAUDE report 18842994 ↗