SimplyGo SimplyGo, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00606959005723), received between Mar 2, 2017 and Apr 20, 2026 — classified as 10 deaths, 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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 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.

• MalfunctionApr 20, 2026Overheating of Device

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLY GO DEVICE. THERE WAS AN ALLEGATION OF ALARMING, FILTER WAS MELTED AND THAT THE SIEVE CANISTER, INLET FILTER KIT WAS REPLACED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924329 ↗
• DeathApr 10, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION IN REGARD TO A USER OF A SIMPLYGO DEVICE HAS PASSED AWAY. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DEATH; HOWEVER, THERE IS NO INFORMATION THAT THE DEATH IS RELATED TO THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 24840650 ↗
• MalfunctionApr 7, 2026Overheating of Device; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING BURNING SMELL. THE UNIT WAS SWAPPED FOR ANOTHER DEVICE AND CONFIRMED THAT THE CUSTOMER ALSO DETECTED A BURNING ODOR AND TAGGED AS "OUT OF SERVICE" AND PLACED ON WORKBENCH. CUSTOMER ATTEMPTED TO POWER ON THE DEVICE USING THE AC ADAPTER BUT THE UNIT DID NOT RESPOND BUT NOTICED THE GREEN LIGHT ON THE ADAPTER WAS FLASHING RATHER THAN REMAINING SOLID. CUSTOMER STATED THEY TRIED TO POWER THE UNIT USING A FULLY CHANGED BUTTER BUT FAILED TO TURN ON. CONTACTED THE REPAIR CENTER REGARDING THEIR ISSUES AND SUGGESTED A POSSIBLE THERMAL EVENT AND A FAULTY PC BOARD. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION, PIL ABLE TO CONFIRM THE CUSTOMER ALLEGATION OF BURNING SMELL DUE TO THERMAL DAMAGE ON THE PCA. THE UNIT ARRIVED AT PIL WITHOUT BATTERY AND POWER SUPPLY. DURING THE INTERNAL INSPECTION IT WAS SHOWED A BLACK RESIDUE ON THE BACK ENCLOSURE (INDICATIVE OF A THERMAL EVENT ON THE PCA). THERMAL DAMAGE ON THE PCA (Q2 AND Q6), SIEVE CANS ARE THE ORIGINAL CANS FROM WHEN THE UNIT WAS MANUFACTURER. A DUST-LIKE CONTAMINATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24806900 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A SIMPLYGO DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH.

  Patient problems: Insufficient Information

  MAUDE report 24737257 ↗
• DeathMar 30, 2026Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A SIMPLYGO HAS PASSED AWAY. ADDITIONALLY, THE REPORTER ALLEGES THAT THE DEVICE STARTS UP, IT PUSHES OXYGEN FOR ABOUT ONE MIN AND IT STOPS PUMPING. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. 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: Insufficient Information

  MAUDE report 24724899 ↗
• DeathAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A DEATH INVOLVING A PHILIPS DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT PASSED AWAY IN NOVEMBER AND THEY WOULD LIKE TO RETURN THE DEVICE AND GET PARTIAL CREDIT DUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE MANUFACTURER IDENTIFIED UNIT HAD 103 HOURS UPON ARRIVAL, REPLACED FRONT COVER DUE TO MECHANICAL CRACK, REPLACED BATTERY DUE TO PRECAUTION, REPLACED SIEVE CANISTER PER PM, REPLACED INLET FILTER PER PM. RUN-IN TESTING PASSED. ALL FUNCTIONAL AND FINAL TESTS PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804867 ↗
• DeathAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A SIMPLYGO PORTABLE OXYGEN CONCENTRATOR DEVICE HAS PASSED AWAY. THE PATIENT¿S WIFE REPORTED THE DEATH AND STATED THAT HER DURABLE MEDICAL EQUIPMENT (DME) PROVIDER HAD INDICATED SHE MIGHT RECEIVE PAYMENT UPON RETURNING THE DEVICE. SHE WAS ADVISED THAT THE MANUFACTURER DOES NOT OFFER COMPENSATION FOR RETURNED DEVICES. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 22698271 ↗
• MalfunctionNov 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A SIMPLYGO DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING EVALUATION OF THE DEVICE, LOW OXYGEN WAS CONFIRMED. SIEVE CANISTER FAILURE AND A MELTED FILTER WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692357 ↗
• DeathOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A CUSTOMER REQUESTING INFORMATION ON RETURNING A SIMPLY GO DEVICE DUE TO A PATIENT PASSING. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED FOR AN ALLEGATION OF A PATIENT DEATH ONLY DUE TO INSUFFICIENT INFORMATION RELATED TO THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 20563622 ↗
• DeathJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF SIMPLYGO THAT ALLEGES THE DEATH OF A PATIENT. 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 19678058 ↗
• DeathApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF SIMPLYGO THAT ALLEGES THE DEATH OF A PATIENT. 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 19015072 ↗
• DeathMar 22, 2024Material Integrity Problem; Material Integrity Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO DEVICE. THE REPORTER ALLEGES THE PATIENT PASSED AWAY WHILE AWAITING THE RETURN OF THE SIMPLYGO UNIT. THE UNIT WAS SENT FOR REPAIR-TO-REPAIR AUTHORITY SINCE SPRING 2022 FOR A SIEVE CANISTER KIT AND INLET FILTER. THE FAMILY OF THE PATIENT DID NOT STATE THE DEVICE WAS THE CAUSE OF THE PATIENT EXPIRING. THE CAUSE OF THE PATIENT'S DEATH WAS NOT PROVIDED BY THE REPORTER. THE DEVICE WAS SENT FOR SERVICE DUE TO THE SIEVE BED "WENT BAD". THE RELATIVE OF THE PATIENT BROUGHT THE DEVICE TO THE PHARMACY FOR REPAIR/REPLACEMENT IN (B)(6) 2022. THE PATIENT PASSED IN (B)(6) 2022 (EXACT DATE NOT PROVIDED). THE RELATIVE OF THE PATIENT THINKS THE PATIENT PASSED AWAY BECAUSE THE PATIENT DID NOT HAVE THE SIMPLYGO DEVICE. 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 18962118 ↗
• MalfunctionMar 21, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLY GO DEVICE'S BATTERY IS BURNED. THE DEVICE HAD TECHNICAL EXAMINATIONS CONDUCTED DURING BENCH REPAIR. THE ENGINEER REPORTS BURN MARKS HAVE BEEN IDENTIFIED ON THE PIN PARTS OF THE DEVICE'S BATTERY. NO BURN MARKS HAVE BEEN FOUND ON THE PARTS OF THE BATTERY LINE LEADING TO THE MAINBOARD. THE DEVICE WAS TESTED WITH A BATTERY USED FOR TESTING PURPOSES IN THE BENCH, AND NO EXTERNAL PROBLEMS HAVE BEEN OBSERVED IN THE BATTERY LINE. IT HAS BEEN DETERMINED BY ME THAT THE BURN PROBLEM ORIGINATES SOLELY FROM THE BATTERY. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER REVIEW. 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 18955238 ↗
• DeathFeb 11, 2024Material Integrity Problem; Material Integrity Problem

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO DEVICE. THE REPORTER ALLEGES THE PATIENT PASSED AWAY WHILE AWAITING THE RETURN OF THE SIMPLYGO UNIT. THE UNIT WAS SENT FOR SERVICING AT A THIRD PARTY SERVICE CENTER SINCE JUNE 2022. THE PATIENT WAS USING A BACK UP UNIT (DEVICE BRAND/TYPE NOT PROVIDED) AT THE TIME OF PASSING. THE FAMILY OF THE PATIENT DID NOT STATE THE DEVICE WAS THE CAUSE OF THE PATIENT EXPIRING. THE CAUSE OF THE PATIENT'S DEATH WAS NOT PROVIDED BY THE REPORTER. THE DEVICE WAS SENT FOR SERVICE DUE TO THE SIEVE BED "WENT BAD". THE RELATIVE OF THE PATIENT BROUGHT THE DEVICE TO THE PHARMACY FOR REPAIR/REPLACEMENT IN (B)(6) 2022. THE DEVICE WAS NOT PICKED UP FOR SERVICING FROM THE PHARMACY UNTIL (B)(6) 2023 ALTHOUGH THE DEVICE WAS IN POSSESSION OF THE PHARMACY SINCE OCTOBER 2022. THE PATIENT PASSED IN (B)(6) 2023 (EXACT DATE NOT PROVIDED). THE RELATIVE OF THE PATIENT THINKS THE PATIENT PASSED AWAY BECAUSE THE PATIENT DID NOT HAVE THE SIMPLYGO DEVICE. 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 18682770 ↗
• MalfunctionSep 28, 2023Device Emits Odor; Smoking; Device Emits Odor; Smoking

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLYGO OXYGEN CONCENTRATOR DEVICE. THE PATIENT ALLEGES THAT ON THE WAY HOME, THE PATIENT BEGAN TO SMELL AN ELECTRICAL BURNING ODOR. THE PATIENT ALLEGES THE SMELL WAS STRONGER AND THE DEVICE WAS SMOKING UPON REACHING HOME. THE PATIENT DID NOT OBSERVE ANY FLAMES AND DID NOT SEE EVIDENCE OF MELTING, WARPING, OR ANY VOIDS IN THE DEVICE ENCLOSURE. ALSO, THE POWER CORD WAS NOT DAMAGED. AT THE TIME OF THE EVENT, THE DEVICE WAS USING BATTERY POWER. THERE WAS NO PROPERTY DAMAGE BEYOND THE DEVICE. 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 17840182 ↗
• MalfunctionSep 22, 2023Failure to Power Up; Excessive Heating; Failure to Power Up; Excessive Heating

  A SIMPLYGO PORTABLE OXYGEN CONCENTRATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND AN ALLEGATION OF THERMAL PCA/NO POWER CONDITION. THERE WAS ALLEGATION OF THE DEVICE BURNED AND MELTED AT THE PB BOARD. NO VOID OR GAPS WERE FOUND IN THE ENCLOSURE OF THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE ALLEGATION OF A THERMAL PCA/NO POWER CONDITION WAS CONFIRMED. PCA COMPONENT Q61 (BATTERY CHARGING CIRCUIT) HAS SHORTED TO THE GROUND AND VENTED FROM AN OVER CURRENT. A VISUAL INSPECTION OF THE DEVICE FOUND MISSING ENCLOSURE FASTENERS, EVIDENCE OF WATER INGRESS, DIRT/DUST/BIOLOGICAL DANDER THROUGHOUT THE UNIT/COOLING PATH, PHYSICAL DAMAGE TO THE MAIN PCA (COMPONENTS BENT 90 DEGREES TO DESIGNED ORIENTATION), AND THERMAL CREEP ISOLATED TO COMPONENT AND LANDS ONLY. THE EXTERIOR BATTERY FAILED DUE TO CELL IMBALANCE AND THE BATTERY CHARGING CIRCUIT FUSIBLE LINK OPENED. THE INVESTIGATION ADDITIONALLY FOUND THERE WAS LACK OF MAINTENANCE, EVIDENCE OF A DROPPED CONDITION, LIQUID INGRESS, AND TAMPERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798547 ↗
• MalfunctionSep 20, 2023Material Integrity Problem; Material Integrity Problem

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO OXYGEN CONCENTRATOR. THE USER ALLEGES THE DC POWER SUPPLY IS FAULTY AND OUT OF WARRANTY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE CENTER REPORTS HIGH PRESSURE, CONTAMINATION, AND ALARMING/RED LIGHT. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780754 ↗
• MalfunctionAug 26, 2023Excessive Heating; Excessive Heating

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A SIMPLYGO DEVICE WAS GETTING HOT AND "HOT TO TOUCH". THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. 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 17628867 ↗
• MalfunctionAug 24, 2023Thermal Decomposition of Device; Excessive Heating; Thermal Decomposition of Device; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO OXYGEN CONCENTRATOR. THE USER ALLEGES THAT THE BATTERY "HAS A READOUT THAT IT HAS BEEN DISCHARGED," DEVICE WILL NOT TURN ON AND CLICKS OFF. THE USE ALLEGES THAT THE BATTERY IS HOT TO THE TOUCH, MATERIAL IS SOFT TO THE TOUCH AND WILL NOT CHARGE. THE DEVICE AND BATTERY ARE OUT OF WARRANTY. THE USER ALLEGES THEY PLAN TO ORDER A NEW BATTERY THROUGH THEIR DOCTOR. 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 17618510 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED THE INFORMATION ALLEGING A SIMPLYGO OXYGEN CONCENTRATOR STOP PROVIDING OXYGEN WHILE IN PATIENT USE. THE PATEINT'S BLOOD OXYGEN LEVEL DECREASED. THE PATIENT WENT TO EMERGENCY ROOM AND WAS PROVIDED OXYGEN. 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: Low Oxygen Saturation

  MAUDE report 15208701 ↗
• InjuryMar 25, 2019Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO OXYGEN CONCENTRATOR SHUT OFF DURING PATIENT USE. THE PATIENT BECAME CYANOTIC AND WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT HAS NOT YET BEEN RELEASED FROM THE HOSPITAL. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8449109 ↗
• MalfunctionJan 28, 2019Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO OXYGEN CONCENTRATOR SHUT DOWN WHILE IN PATIENT USE. THE PATIENT FAINTED AND WAS TAKEN TO THE HOSPITAL AND PLACED ON LIFE SUPPORT. THE PATIENT WAS IN THE HOSPITAL FOR 6 DAYS. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8282209 ↗
• InjuryNov 21, 2017Failure to Deliver; Device Operational Issue; Device Operational Issue

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO OXYGEN CONCENTRATOR WAS NOT PRODUCING OXYGEN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Cardiac Arrest; No Code Available

  MAUDE report 7049011 ↗
• InjuryAug 30, 2017Device Operational Issue; Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Operational Issue

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO OXYGEN CONCENTRATOR WAS NOT WORKING PROPERLY AND WAS NOT ALARMING. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Low Oxygen Saturation; No Information

  MAUDE report 6829976 ↗
• InjuryAug 23, 2017Device Operational Issue; Loss of Power; Device Operates Differently Than Expected; Device Operational Issue

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO OXYGEN CONCENTRATOR WAS NOT PRODUCING OXYGEN AND SHUT DOWN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SHORTNESS OF BREATH. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

  Patient problems: Dyspnea; Increased Respiratory Rate

  MAUDE report 6813264 ↗