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

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00606959032439), received between Feb 12, 2021 and Jun 2, 2026 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (8 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Excessive Heating

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNED 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 25368935 ↗
• MalfunctionDec 18, 2025Smoking; Smoking

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO SIMPLYGO MINI DEVICE. THERE WAS AN INITIAL ALLEGATION OF SMOKE COMING OUT FROM THE DEVICE. ADDITIONALLY, BATTERY POWER BEING LOW AND VERY LOUD NOISE KNOCKING AT LEVEL 5. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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 23843658 ↗
• MalfunctionDec 8, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE SIMPLYGO MINI DEVICE WOULD NOT CHARGE. THERE WAS NO DEATH, SERIOUS HARM OR INJURY WERE REPORTED, AND NO MEDICAL INTERVENTION WAS PROVIDED. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND THAT THE DEVICE HAD A BURNT PCA (PRINTED CIRCUIT ASSEMBLY). 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 23750817 ↗
• MalfunctionNov 13, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED A WORK ORDER REPORTING THAT THE SIMPLYGO MINI DEVICE WAS EVALUATED BY A SERVICE CENTER, AND THIS DEVICE HAS BEEN SERVICED. THE SERVICE TECHNICIAN FOUND PCA IS BURNED, AIR SIDE AND O2 SIDE ARE LEAKING AIR, SIEVES ARE CLOGGED, AND THE INLET FILTER WILL BE REPLACED DUE PM. THERE WAS 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 23544027 ↗
• MalfunctionOct 27, 2025Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO MINI DEVICE WITH A CUSTOMER ALLEGATION OF DEVICE WITH NO DETAILS. 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 23389633 ↗
• MalfunctionAug 20, 2025Overheating of Device; Overheating of Device

  DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THERE WAS EVIDENCE OF A BURNT PCA. DURING THE INVESTIGATION, SEVERAL COMPONENTS OF THE DEVICE WERE FOUND TO HAVE ISSUES: FRONT ENCLOSURE & INTERNAL CABLE AND SHIELD, AND SIEVES ARE BURNT. OXYGEN SIDE AND AIR SIDE ARE DEFECTIVE, COMPRESSOR TUBING IS DAMAGED, LABELS NEED TO BE REPLACED. THE DEVICE WILL BE SENT TO PIL FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854605 ↗
• MalfunctionJun 8, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A SIMPLY GO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR MAINTENANCE OF SIEVE. DURING THE INITIAL EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE UNIT AND FOUND THE PCA HAD THERMAL DAMAGE. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO ALLEGATION OF PATIENT OR USER HARM OR INJURY. THE DEVICE IS BEING SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. 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 22164402 ↗
• MalfunctionMay 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A SIMPLY GO MINI DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE INITIAL EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE UNIT AND FOUND THE PCA HAD THERMAL DAMAGE. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO ALLEGATION OF PATIENT HARM OR INJURY. THE UNIT IS BEING SHIPPED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. 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 22041086 ↗
• MalfunctionDec 31, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  AN OXYGEN CONCENTRATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REPAIRS OF A PRODUCT MALFUNCTION. THE PATIENT REPORTED ALLEGATIONS OF A BURNING SMELL COMING FROM THE DEVICE. THERE WERE NO ALLEGATIONS OF HARM OR SERIOUS INJURY. MEDICAL INTERVENTION WAS NOT SPECIFIED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF A BURNT PCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047171 ↗
• MalfunctionDec 30, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF PATIENT HARM, SERIOUS INJURY, OR MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO AN AUTHORIZED SERVICE CENTER FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED. DURING THE EVALUATION THE SERVICE CENTER FOUND PCA WAS BURNED. IN ADDITION, SIEVE ARE CLOGGED, O2 SIDE IS DEFECTIVE, AIR SIDE AND COMPRESSOR ARE CONTAMINATED, THE BATTERY PCA AND REAR COVER BE REPLACED. LASTLY ALL TEST RESULT PASSED. DEVICE WAS SCRAPPED. POWER CONNECTER DESTROYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035971 ↗
• MalfunctionDec 29, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE WERE SOME SECONDARY FINDINGS LIKE PCA BURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032225 ↗
• MalfunctionDec 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS PCA BURN WERE OBSERVED. 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 20915737 ↗
• MalfunctionDec 3, 2024Device Emits Odor; Smoking; Electrical Shorting; Device Emits Odor; Smoking; Electrical Shorting

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR HAD A BURNING SMELL, A SHORTED INPUT POWER SYSTEM, AND SMOKE CAME OUT OF THE BACK OF THE CONCENTRATOR WHILE IT WAS CHARGING. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PRODUCT INVESTIGATION LAB CONFIRMED THE MAIN PCA (COMPONENTS C128) CIRCUIT TRACE OPEN CONDITION WHICH RESULTED FROM A "SHORT TO GROUND," APPEARS TO BE AN EOS/ESD EVENT. FURTHERMORE, THE THERMALLY STRESSED COMPONENT VENTED, AND NO FURTHER DAMAGE WAS CONFIRMED. THIS THERMAL EVENT IS ISOLATED TO THE PRINTED CIRCUIT ASSEMBLY SUBSTRATE (GROUND) TRACE AREA AND COMPONENTS. COMPONENT VENTING IS ISOLATED TO THE COMPONENT AND SOLDER LANDS ONLY. NO EVIDENCE OF CREEPING IS FOUND. INDICATIVE OF COMPRESSOR IN NEED OF REPLACEMENT/OVERSTRESSED FROM DUTY CYCLE/WORN PARTS/IN NEED OF MAINTENANCE. UPON VISUAL INSPECTION, THE UNIT APPEARS TO HAVE BEEN DROPPED/NEGLECTED/TAMPERED. THERE ARE MULTIPLE POINTS OF PHYSICAL DAMAGE. THE MAIN PCA APPEARS TO HAVE TAKEN A VOLTAGE SPIKE OR EOS/ESD. COMPONENTS C128 (POWER INLET CHOKE) HAVE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835754 ↗
• MalfunctionAug 23, 2024Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING BLACK PARTICLES SPITTING OUT OF O2 SPOUT. THERE IS 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 INVESTIGATION. 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 20056364 ↗
• MalfunctionJul 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF PATIENT HARM, SERIOUS INJURY, OR MEDICAL INTERVENTION. THE DEVICE WAS RETURNED TO AN AUTHORIZED SERVICE CENTER FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED. DURING THE EVALUATION THE SERVICE CENTER FOUND PCA WAS BURNED. IN ADDITION, SIEVE CANISTER IS CLOGGED, O2 SIDE IS DEFECTIVE, AIR SIDE AND INLET FILTER ARE CONTAMINATED. LASTLY ALL TEST RESULT PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805079 ↗
• MalfunctionMay 10, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO PCA-TECHNICAL FAULT AND VERY LOW OXYGEN, THE POWER CONNECTOR WAS BROKEN, 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. THIS REPORT IS BEING SUBMITTED DUE TO A POSSIBLE THERMAL EVENT ON THE AIR SIDE OF THE PORTABLE CONCENTRATOR. 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 19286595 ↗
• MalfunctionMar 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE DEVICE WAS EVALUATED BY A SERVICE TECHNICIAN. THE TECHNICIAN REPORTS PCA IS BURNED. IN ADDITION, THE TECHNICIAN REPORTS SIEVES ARE CLOGGED, O2 AND AIR SIDE CRACKED, COMPRESSOR DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856982 ↗
• MalfunctionMar 5, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE DEVICE AS EVALUATED BY A SERVICE TECHNICIAN. THE TECHNICIAN REPORTS PCA BOARD BURNED/DAMAGED, BALANCING VALVE DEFECTIVE, SIEVE CANISTERS ARE DEFECTIVE, AIR SIDE CONTAMINATED, THE COMPRESSOR AND O2 ARE DEFECTIVE, MAINTENANCE LABEL NEEDED CHANGED. THERE IS NO ALLEGATION OF SMOKE OR FIRE FROM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842373 ↗
• MalfunctionDec 21, 2023Inaccurate Flow Rate; Noise, Audible; Inaccurate Flow Rate; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S WAREHOUSE. PER THE WORK ORDER, THE DEVICE WAS NOISY. THE COMPRESSOR WAS REPLACED. DURING INSPECTION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE O2 SIDE ASSEMBLY COMPONENT FAILURE, THE AIR SIDE MANIFOLD WAS CRACKED, LOW O2, AND NO POWER FLOWING TO THE POWER CONNECTOR. ALL FAILING COMPONENTS WERE REPLACED. 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 18379949 ↗
• MalfunctionDec 21, 2023Improper Flow or Infusion; Noise, Audible; Excessive Heating; Improper Flow or Infusion; Noise, Audible; Excessive Heating

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE CUSTOMER ALLEGED THE DEVICE RUNS IRREGULARLY, GETS WARM, AND WHISTLES. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE CLOGGED SIEVES, AND THE AIR SIDE, O2 SIDE, AND COMPRESSOR WERE CONTAMINATED. THE DEFECTIVE PARTS WERE REPLACED. THE DEVICE WAS SERVICE, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH THE THIRD PARTY SERVICE CENTER. 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 18370561 ↗
• MalfunctionDec 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE A CONTAMINATED COMPRESSOR. THE AIR SIEVE WAS CONTAMINATED, THE O2 SIDE SCREW THREAD WAS DAMAGED, AND THE SIEVE WAS CLOGGED. THE FRONT COVER WAS DAMAGED. ALSO, THE ALARM SENSOR HAD DAMAGED WIRE. 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 18323724 ↗
• MalfunctionDec 13, 2023Gas/Air Leak; Gas/Air Leak

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE A CLOGGED SIEVE, THE O2 SIDE SCREW THREAD CRACKED, AN AIR SIDE LEAK. ALSO, THE COMPRESSOR WAS OVERHEATING. 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 18323349 ↗
• MalfunctionDec 13, 2023Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE SIEVES WERE FOUND TO BE CLOGGED (THE O2 AND AIR SIDE WAS CONTAMINATED), AND THE COMPRESSOR WAS FOUND TO BE DEFECTIVE (OVERHEATING). 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 18322736 ↗
• MalfunctionOct 16, 2023Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED BY THE DISTRIBUTOR IN REFERENCE TO A SIMPLYGO MINI OXYGEN CONCENTRATOR. THE DISTRIBUTOR ALLEGES REPAIRING THE DEVICE DUE TO A BROKEN POWER CONNECTOR. THE DISTRIBUTOR HAS REQUESTED FOC COMPRESSOR INLET FILTERS AND SIEVE CANISTER. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. THERE IS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 17942079 ↗
• InjuryDec 28, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WAS HOSPITALIZED WITH PULMONARY EMBOLISM ALLEGEDLY CAUSED BY THE SIMPLYGO MINI OXYGEN CONCENTRATOR. THE MEDICAL TREATMENT IS UNKNOWN. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE IS NOT RETURNING TO THE MANUFACTURER FOR EVALUATION. THE SALES OFFICE CHECKED THE DEVICE AND FOUND THE DEVICE TO OPERATE WITH NO ISSUES.

  Patient problems: Pulmonary Embolism

  MAUDE report 13093602 ↗