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

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00606959032392), received between Jun 4, 2018 and Apr 29, 2026 — classified as 7 deaths, 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (5 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 37 reports, in the reporter's own words as published by the FDA.

• DeathApr 29, 2026Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A SIMPLYGO MINI HAS PASSED AWAY. IT IS ALLEGED THAT THE CAUSE OF DEATH WAS CARDIAC ARREST FROM USING THE DEVICE. THE REPORTED EVENT MAKES NO ALLEGATION OF MALFUNCTION OR FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS WAS NOTED REGARDING THE DEVICE DURING THE TIME OF THE PATIENT USE, USER 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: Cardiac Arrest

  MAUDE report 25027140 ↗
• DeathMar 3, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH SIMPLY GO MINI 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. 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 24502981 ↗
• DeathSep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT HAS BEEN REVIEWED AND IT HAS BEEN DETERMINED THAT THE CUSTOMER HAS ALLEGED PATIENT PASSED AWAY. 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 22962796 ↗
• MalfunctionAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A SIMPLYGO PORTABLE OXYGEN CONCENTRATOR DEVICE. THE PATIENT ALLEGES FOR CREDIT REQUEST. NO INFORMATION WAS REPORTED REGARDING THE OBSERVATION OF ANY FLAMES OR EVIDENCE OF MELTING, WARPING, OR ANY VOIDS IN THE DEVICE ENCLOSURE. THERE WAS ALSO NO REPORT OF ANY PROPERTY DAMAGE. DURING EVALUATION OF THE DEVICE, THE SECONDARY FINDING IS OBSERVED THAT CORROSION ON MAIN PCA, AND PCA NEED TO REPLACE, AND UNIT IS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852223 ↗
• MalfunctionApr 23, 2025Device Emits Odor; Device Emits Odor

  THIS NOTIFICATION IS BEING REVIEWED DUE TO A USER OF SIMPLYGO MINI. THE USER REPORTS THE UNIT HAS BURNING SMELL WHEN TURNED ON ALSO HAS A CAUTION LIGHT. ALTHOUGH THERE WAS NO REPORTED PATIENT DEATH OR SERIOUS INJURY, THIS COMPLAINT IS REPORTABLE BECAUSE THE REPORTED ISSUE/EVENT IMPACTS OR POTENTIALLY IMPACTS THERAPY, WHICH COULD 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 21894939 ↗
• DeathApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT PASSED AWAY, AND HIS WIFE REACHED OUT TO INQUIRE ABOUT HOW TO DISPOSE OF THE SIMPLYGO MINI DEVICE. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. NO MEDICAL INTERVENTION WAS REPORTED. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866911 ↗
• MalfunctionJan 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF A SIMPLY GO MINI STATING THAT THE DEVICE IS GETTING A TECH FAULT ALARM. THE DEVICE WAS RETURNED TO A THIRD- PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE DEVICE THEY FOUND OUT THAT THE PCA OF THE BURNED BATTERY. IN ADDITION, FAILURES IN BATTERY PCA BURNED, RP-SIMPLY GO MINI-COMPRESSOR CONTAMINATED, R-AIR SIDE MANIFOLD ASSEMBLY, SGM CONTAMINATED, RP-SIMPLY GO MINI REAR ENCLOSURE DAMAGE, SIMPLY GO MINI FRONT COVER DAMAGE. RP-SGM WARNING LABEL INTLRIST. ERROR CODES ARE FOUND IN THE DEVICE. THE COMPRESSOR, BATTERY PCA, SIEVE BED CANISTER ARE GOING TO BE REPLACED. THE DEVICE WAS ROUTED TO SCRAP. 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 21124281 ↗
• DeathJan 7, 2025Degraded; Degraded

  THE MANUFACTURER BECAME AWARE THAT A USER OF THE RECERT SIMPLYGO MINI HAD PASSED AWAY AND THE DEVICE WAS ELIGIBLE FOR BUYBACK. 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: Insufficient Information

  MAUDE report 21096623 ↗
• DeathNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT'S HUSBAND STATING THAT HIS WIFE HAD PASSED AWAY. BASED ON AVAILABLE INFORMATION AT THIS TIME, THE ALLEGED HARM DEATH IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. THEREFORE, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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 20778297 ↗
• 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 20563709 ↗
• InjuryOct 23, 2024No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT THE SIMPLYGO MINI DEVICE HAD A YELLOW ALARM DISPLAYED, AND THE UNIT GOT HOT AND TURNED OFF. THE CUSTOMER ALLEGED THE DEVICE MALFUNCTION CAUSED HER OXYGEN TO DROP TO 56 AND HER LIPS TO TURN BLACK (HYPOXIA). NO MEDICAL INTERVENTION WAS REPORTED. 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: Hypoxia

  MAUDE report 20518066 ↗
• MalfunctionOct 4, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED AN ALLEGATION FOR A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO LOW O2. THE COMPLAINT WAS CONFIRMED, AND PARTS WERE REPLACED AT A SERVICE CENTER. THE SIEVE BEDS WERE FOUND WITH LOW O2, THE O2 SIDE CHECK VALVES MALFUNCTION, THE AIRSIDE MANIFOLD IS CHIRPING. PERIODIC MAINTENANCE WAS PERFORMED ON THE INLET FILTER AND TUBING. THE COMPRESSOR HAD LEAD WIRE DAMAGE, THE PCA BOARD HAD THERMAL DAMAGE, AND THE REAR ENCLOSURE WAS CRACKED. THE SIMPLYGO MINI SOFTWARE WAS UPDATED. 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 20368961 ↗
• MalfunctionOct 3, 2024Backflow; Overheating of Device; Backflow; Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR WAS OVERHEATING AND CAUSED DAMAGE TO THE PC BOARD. THERE WAS NO REPORT OF SMOKE, FLAMES, OR EXPOSED AC WIRES. 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, BUT THE INVESTIGATION IS NOT YET COMPLETE. 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 20358578 ↗
• MalfunctionAug 6, 2024Degraded; Power Problem; Degraded; Power Problem

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR AN SIMPLYGO OXYGEN CONCENTRATOR DUE TO ALARMING; CABINETS MELTED; ABLE TO DUPLICATE PROBLEM DUE TO FOUND SIEVE BEDS WITH HEALTH MESSAGE, INLET FILTER PM, TUBING WORN, AIRSIDE MANIFOLD CHIRPING, O2 SIDE CHECK VALVE MALFUNCTION, MAIN PCA BOARD HAS INTERMITTENT OPERATION, COMPRESSOR HAS LEAD WIRE DAMAGE. THIS REPORT IS BEING SUBMITTED DUE TO O2 SIDE CHECK VALVE MALFUNCTION AND THE COMPRESSOR HAS LEAD WIRE DAMAGE. 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 19924577 ↗
• MalfunctionJul 17, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO DIAGNOSTIC TEST ATTEMPTED; SHUTS DOWN; PCA BURNT; FRONT COVER TOUCH SCREEN NOT WORKING; PATIENT DELIVERY VALVE AND BALANCING VALVE NOT WORKING; AIRSIDE MANIFOLD SQUEAKING; O2 SIDE CRACKED. 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 A THERMAL EVENT ON THE PCA. 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 19762638 ↗
• MalfunctionJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING EYE IRRITATION, NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, HYPERSENSITIVITY, NAUSEA / VOMITING, INFLAMMATORY RESPONSE. 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: Eye Irritation; Hypersensitivity/Allergic reaction; Inflammation; Unspecified Respiratory Problem; Vomiting

  MAUDE report 19454730 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, NAUSEA, VOMITING, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, REDUCED CARDIOPULMONARY RESERVE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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: Dizziness; Headache; Inflammation; Nausea; Skin Inflammation/ Irritation; Unspecified Heart Problem; Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem; Vomiting

  MAUDE report 19298577 ↗
• MalfunctionApr 15, 2024Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A WORK ORDER INVOICE FOR A SIMPLYGO MINI PORTABLE OXYGEN CONCENTRATOR DUE TO THE SIEVE BEDS HAVING LOW O2; FRONT SCREEN WAS CRACKED; THE BATTERY PCA WAS BURNT; AIRSIDE MANIFOLD LEAKING. 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 A THERMAL EVENT ON THE BATTERY PCA. 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 19104688 ↗
• MalfunctionApr 8, 2024Crack; Insufficient Flow or Under Infusion; Noise, Audible; Crack; Insufficient Flow or Under Infusion; Noise, Audible

  THE MANUFACTURER WAS CONTACTED REGARDING A SIMPLYGO MINI DEVICE. A FASC REPRESENTATIVE VISUALLY INSPECTED THE DEVICE, AND THE COMPLAINT WAS CONFIRMED: LOW O2, INLET FILTER PM, TUBING PM, AND BROKEN POWER CONNECTOR. THE SERVICE TECHNICIAN REPLACED THE DEFECTIVE PARTS AND UPDATED THE SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057192 ↗
• MalfunctionMar 15, 2024Noise, Audible; Noise, Audible

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A SIMPLYGO MINI. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING EVALUATION OF THE DEVICE, THE PLUG WAS FOUND TO BE "PUSHED IN" THE MOTOR MOUNTS WERE WORN, AND THE DEVICE MADE A WHISTLING/CHIRPING NOISE. 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 18918211 ↗
• MalfunctionFeb 27, 2024Material Deformation; Material Deformation

  THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A SIMPLYGO MINI OXYGEN CONCENTRATOR DEVICE. THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN. THE TECHNICIAN REPORTS A BURNED POWER CORD. IN ADDITION, THE TECHNICIAN REPORTS SIEVE BEDS LOW O2, MANIFOLD ASSEMBLY SQUEAKS, MANIFOLD ASSEMBLY CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789267 ↗
• 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 18682769 ↗
• MalfunctionJan 24, 2024Gas Output Problem; Noise, Audible; Gas Output 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 WERE FOUND WITH LOW O2, MALFUNCTIONING VALVES, AIRSIDE MANIFOLD CHIRPING, AND INLET FILTER PM. TUBING PM, AND THE POWER CONNECTOR BROKEN. AFTER THE COMPREHENSIVE EVALUATION, THE NECESSARY PARTS WERE REPLACED, AND THE SOFTWARE WAS UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568367 ↗
• 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 CONNECTOR]. 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 18560351 ↗
• 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 CONNECTOR. 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 18560350 ↗