DeVilbiss 525DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 00885304000846), received between Dec 21, 2016 and Sep 3, 2026 — classified as 14 deaths, 27 injuries, 246 malfunctions.

The most frequently reported specific device problem is “Low Readings” (100 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K071397); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 9, 2023Open, Classified

   The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

   Z-1558-2023 · Root cause: Labeling design · FDA record ↗

2. Nov 18, 2022Open, Classified

   The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

   Z-0724-2023 · Root cause: Labeling False and Misleading · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.

• DeathSep 3, 2026Fire

  Drive Medical was notified of an incident involving an oxygen concentrator from a device provider's attorney regarding a house fire where the patient passed away in the fire and also another tenant in the apartment complex. Drive Medical is currently investigating the incident, including attempting to inspect the device. An update will be filed if additional information becomes available.

  Patient problems: Burn(s)

  MAUDE report 50591474 ↗
• DeathSep 3, 2026Fire

  Drive Medical was notified of an incident involving an oxygen concentrator from a device provider's attorney regarding a house fire where the patient passed away in the fire and also another tenant in the apartment complex. Drive Medical is currently investigating the incident, including attempting to inspect the device. An update will be filed if additional information becomes available.

  Patient problems: Burn(s)

  MAUDE report 50590665 ↗
• InjurySep 3, 2026Fire

  Drive Medical was notified of an incident involving an oxygen concentrator from a device provider's attorney regarding injury from a concentrator fire causing burns to the end user's face and throat. Drive Medical is currently investigating the incident, including attempting to inspect the device. An update will be filed if additional information becomes available.

  Patient problems: Burn(s)

  MAUDE report 50587111 ↗
• DeathSep 2, 2026Fire

  Drive Medical was notified of an incident involving an oxygen tank from a device provider's attorney regarding a death from and oxygen tank allegedly causing a house fire. Drive Medical is currently investigating the incident, including attempting to inspect the device. An update will be filed if additional information becomes available.

  Patient problems: Burn(s)

  MAUDE report 50567508 ↗
• DeathSep 2, 2026Fire

  Drive Medical was notified of an incident involving an oxygen concentrator from a device provider's attorney regarding a death related to an oxygen concentrator fire. No allegations and cause of fire unknown. Drive Medical is currently investigating the incident, including attempting to inspect the device. An update will be filed if additional information becomes available.

  Patient problems: Burn(s)

  MAUDE report 50566128 ↗
• InjuryJul 22, 2026Use of Device Problem

  DRIVE MEDICAL WAS NOTIFIED VIA A VOLUNTARY MEDWATCH REPORT THAT AN END USER LIT A CIGARETTE WHILE USING THE OXYGEN CONCENTRATOR AND RECEIVED SECOND DEGREE BURNS TO THEIR FACE. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE THE CANNULA AND LEAVE THE ROOM WHERE EITHER THE CANNULA OR MASK OR THE OXYGEN CONCENTRATOR IS LOCATED. IF UNABLE TO LEAVE THE ROOM, YOU MUST WAIT 10 MINUTES AFTER YOU HAVE TURNED OFF THE OXYGEN CONCENTRATOR BEFORE SMOKING. OX

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25908860 ↗
• InjuryJun 2, 2026Insufficient Device Problem Information

  DRIVE MEDICAL WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THAT THE DEVICE POWERED UP WITH A YELLOW LIGHT, THEN IT ALARMED AND THE RED LIGHT CAME ON, AND THE END USER WAS UNSURE IF THE OXYGEN CONCENTRATOR SHUT DOWN. THE END USER REPORTED THAT THE PORTABLE OXYGEN SYSTEM WAS NOT WORKING PROPERLY. THE PARAMEDICS WERE CALLED AND THE END USER WAS TAKEN TO THE HOSPITAL. THE PRODUCT'S INSTRUCTION MANUAL STATES: "THE DEVICE IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. WHEN THE UNIT IS TURNED ON, ALL THREE LIGHTS (SERVICE REQUIRED, LOW OXYGEN AND NORMAL OXYGEN) ON THE FRONT PANEL WILL ILLUMINATE BRIEFLY AND AN AUDIBLE SIGNAL WILL BRIEFLY ALARM CONFIRMING THAT THE LEDS AND AUDIBLE SIGNAL ARE FUNCTIONING PROPERLY. THE UNIT WILL THEN OPERATE IN START UP MODE WITH THE LOW OXYGEN LIGHT LIT UNTIL A NORMAL OXYGEN LEVEL IS ACHIEVED, AT WHICH TIME THE NORMAL OXYGEN LIGHT WILL REMAIN LIT. THE START UP MAY TAKE UP TO 15 MINUTES. IF ANY OF THE LIGHTS ON THE FRONT PANEL DO NOT ILLUMINATE OR THE AUDIBLE ALARM DOES NOT SOUND, THIS INDICATES THE ALERT SYSTEM IS NOT FUNCTIONING PROPERLY. THE DEVILBISS 5 LITER OXYGEN CONCENTRATOR MAY BE CONTRAINDICATE

  Patient problems: Low Oxygen Saturation

  MAUDE report 25361959 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AND OXYGEN CONCENTRATOR THAT DISPLAYED RED LIGHTS, AUDIBLY ALARMED DURING USE, THE END USER WAS PLACED ON A RESERVE BACK UP OXYGEN SYSTEM AND WAS TAKEN TO THE EMERGENCY ROOM FOR LOW OXYGEN SATURATION AND HIGH BLOOD PRESSURE. THE PRODUCT'S INSTRUCTIONS FOR USE STATE: THE DEVICE IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING' AND 'IF YOUR UNIT LOSES ELECTRICAL POWER OR FAILS TO OPERATE CORRECTLY, THE PATIENT ALERT SYSTEM WILL SOUND TO SIGNAL YOU TO SWITCH TO YOUR RESERVE OXYGEN SYSTEM AND CONTACT YOUR DEVILBISS PROVIDER.' DEVILBISS HEALTHCARE HAS REQUESTED THE RETURN OF THE DEVICE FOR EVALUATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: High Blood Pressure/ Hypertension; Low Oxygen Saturation

  MAUDE report 25044882 ↗
• InjuryFeb 25, 2026Thermal Decomposition of Device

  DEVILBISS HEALTHCARE RECEIVED A REPORT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER'S DAUGHTER WHO REPORTED THE CONCENTRATOR EMITTED A POPPING SOUND AND SUBSEQUENTLY IGNITED THE NASAL CANNULA. ACCORDING TO THE INFORMATION PROVIDED, THE CANNULA TUBING CAUGHT FIRE, AND THE FLAME TRAVELED UPWARD ALONG THE TUBING THAT WAS LAYING ON THE END USER'S LEG, RESULTING IN THIRD DEGREE BURNS TO THE END USER'S UPPER THIGH. THE REPORTER INDICATED THAT THERE WERE NO OPEN FLAMES, SMOKING MATERIALS, OR OTHER OBVIOUS EXTERNAL IGNITION SOURCES PRESENT AT THE TIME OF THE EVENT. FOLLOWING THE INJURY, THE PATIENT WAS EVALUATED AT A BURN CENTER AND LATER CONTINUED TREATMENT AT HOME. THE DEVICE PROVIDER REPLACED THE CONCENTRATOR FOLLOWING THE INCIDENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE AFFECTED UNIT FOR INVESTIGATION; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT BEEN RETURNED TO DEVILBISS FOR EVALUATION. DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24444850 ↗
• InjuryJan 28, 2026Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER, WHO REPORTED THAT THEY WERE SMOKING WHILE USING THE DEVICE. THE END USER SUFFERED SECOND DEGREE BURNS TO HER FACE, NECK, CHEST AND HAIR. THE END USER WAS TAKEN TO THE HOSPITAL BY AMBULANCE AND RELEASED THE SAME DAY. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE DEVICE WAS SERVICED BY THE PROVIDER. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE TH

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24200371 ↗
• InjuryJan 21, 2026Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR VIA A PROVIDER'S VOLUNTARY MEDWATCH REPORT WHICH STATED THE END USER WAS SMOKING WHILE USING THE OXYGEN CONCENTRATOR, IGNITING THE OXYGEN CANNULA. THE END USER WAS ADMITTED TO THE HOSPITAL FOR FIRST AND SECOND DEGREE BURNS TO THEIR FACE AND CHEST. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE DEVICE IS NOT RETURNING FOR EVALUATION. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRA

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 24132099 ↗
• InjuryJan 9, 2026Gas Output Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR REPORTED BY THE END USER AS NOT DELIVERING OXYGEN. ACCORDING TO THE INFORMATION PROVIDED, THE END USER SUBSEQUENTLY REQUIRED HOSPITALIZATION. NO ADDITIONAL CLINICAL DETAILS REGARDING THE HOSPITALIZATION WERE MADE AVAILABLE. THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO DEVILBISS HEALTHCARE FOR EVALUATION; THEREFORE, NO DEVICE ANALYSIS WAS CONDUCTED, AND CONFIRMATION OF THE ALLEGED DEVICE MALFUNCTION COULD NOT BE PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 24025920 ↗
• DeathDec 3, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED BY THE PROVIDER OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR. THE PROVIDER REPORTED THAT A FIRE OCCURRED, RESULTING IN THE DEATH OF THE END USER. ADDITIONAL INFORMATION WAS OBTAINED FROM THE END USER'S DAUGHTER, WHO STATED THAT THE PATIENT LIT A CIGARETTE WHILE USING THE OXYGEN CONCENTRATOR. THE PATIENT SUSTAINED FACIAL BURNS, WAS HOSPITALIZED, AND SUBSEQUENTLY PASSED AWAY. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR

  Patient problems: Burn(s)

  MAUDE report 23707595 ↗
• MalfunctionNov 5, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A THIRD-PARTY SERVICE CENTER, WHICH REPORTED THE DEVICE HAD EVIDENCE OF MELTING TO THE FRONT ENCLOSURE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE DAMAGE WAS CONCENTRATED AT THE FRONT OF THE UNIT, AT THE HUMIDIFIER RECESS CAVITY, AND THERE WAS NO INTERNAL DAMAGE TO THE UNIT. IT IS BELIEVED THAT THE FIRE ORIGINATED FROM AN EXTERNAL SOURCE AND TRAVELED TO THE OUTLET PORT OF THE UNIT VIA THE CANNULA TUBING. THE METAL OUTLET FITTING OF THE DEVICE WAS FOUND TO BE MISSING WHEN THE DEVICE WAS RECEIVED, BUT THIS WAS LIKELY DUE TO THE DAMAGE SUSTAINED TO THE OUTLET PORT, WHICH CAUSED IT TO DETACH FROM THE FRONT COVER. THE METAL OUTLET FITTING IS DESIGNED TO PREVENT FIRE INGRESS TO THE DEVICE. ALTHOUGH THE OUTLET FITTING WAS MISSING FROM THE UNIT, IT PREVENTED FIRE INGRESS BEFORE DETACHING FROM THE UNIT. THE UNIT HAD EVIDENCE OF BEING OPERATED IN AN AREA WHERE CIGARETTES WERE IN USE. THE INTAKE TUBING, GROMMET, INTAKE FILTER, AND INTAKE COMPARTM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23481637 ↗
• InjuryAug 27, 2025Mechanical Problem; Mechanical Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER WHO REPORTED THE DEVICE WAS NOT PUTTING OUT ENOUGH OXYGEN AND WAS ALARMING. THE END USER BECAME SHORT OF BREATH AND ADMINISTERED A NEBULIZER TREATMENT. THE END USER CALLED EMS AND STATED THAT SHE "PASSED OUT." THE END USER WAS ADMITTED TO THE HOSPITAL FOR A COUPLE DAYS. THE END USER IS CURRENTLY ON STEROIDS. PRODUCT LABELING STATES," IF YOU FEEL DISCOMFORT OR ARE EXPERIENCING A MEDICAL EMERGENCY WHILE UNDERGOING OXYGEN THERAPY, SEEK MEDICAL ASSISTANCE IMMEDIATELY TO AVOID HARM. AS A PRECAUTION, YOUR DEVILBISS PROVIDER MAY SUPPLY YOU WITH A RESERVE OXYGEN SYSTEM. IF YOUR UNIT LOSES ELECTRICAL POWER OR FAILS TO OPERATE CORRECTLY, THE PATIENT ALERT SYSTEM WILL SOUND TO SIGNAL YOU TO SWITCH TO YOUR RESERVE OXYGEN SYSTEM (IF PROVIDED) AND CONTACT YOUR DEVILBISS PROVIDER." THE DEVICE OPERATED TO DESIGN SPECIFICATIONS BY ALARMING TO ALERT THE USER OF AN EVENT. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 22905204 ↗
• MalfunctionJul 16, 2025Temperature Problem; Temperature Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO STATED THAT THE DEVICE BECAME HEATED, CAUSING THE SIEVE BEDS TO FAIL AND THE COMPRESSOR BOX TO WARP. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, THE THERMAL EVENT WAS LIMITED TO THE COMPRESSOR BOX AND INTAKE FILTER, WITH SLIGHT DAMAGE TO THE REAR COVER, AT THE INTAKE FILTER CUT-OUT. EVIDENCE OF MISHANDLING WAS OBSERVED IN THAT MULTIPLE SCREW BOSSES WERE CRACKED AND ONE OF THE WHEEL BOSSES WAS DAMAGED. THE FAN AND ALARM SYSTEM WERE BOTH FOUND TO BE WORKING CORRECTLY, HOWEVER THE THERMAL CUT-OFF WITHIN THE COMPRESSOR WAS INOPERABLE. THE UNIT HAD EVIDENCE OF BEING REPAIRED EVEN THOUGH THERE WERE NO PREVIOUS REPAIR RECORDS FOR THIS UNIT. THE MANIFOLD WAS FOUND TO BE A HIGH-PRESSURE MANIFOLD, INSTEAD OF A LOW-PRESSURE MANIFOLD AND THE HOSE FROM THE RIGHT SIEVE BED TO THE MANIFOLD WAS INCORRECTLY ROUTED. THE SERIAL NUMBER ON THE VALVE DID NOT MATCH THE SERIAL NUMBER OF THE VALVE IN THE UNIT DHR. THE COMPRESSOR WAS FOUND TO BE MISSING THE SERIAL NUMBER STICKER, SO IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522092 ↗
• MalfunctionJul 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF A DEVICE MALFUNCTION INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER, WHO STATED THAT THE POWER CORD HAS EXPOSED WIRES. THE DEVICE IS PAST ITS STATED FIVE-YEAR USE LIFE. THE INSTRUCTION MANUAL FOR THIS DEVICE INCLUDES WARNINGS STATING "IMPROPER USE OF THE POWER CORD AND PLUGS CAN CAUSE A BURN, FIRE OR OTHER ELECTRIC SHOCK HAZARDS. DO NOT USE THE UNIT IF THE POWER CORD IS DAMAGED. ENSURE THE MAINS POWER CORD IS FULLY INSERTED INTO THE CONCENTRATOR CONNECTOR (230 VOLT UNITS) AND THE POWER CORD PLUG IS COMPLETELY INSERTED INTO A FULLY FUNCTIONING AC WALL OUTLET. FAILURE TO DO SO MAY CAUSE AN ELECTRICAL SAFETY HAZARD." THERE IS NO ALLEGATION OF FIRE, SPARKS, OR SMOKE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478699 ↗
• InjuryJul 3, 2025Fire; Fire

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER'S DAUGHTER THAT SHE DISCOVERED THE DEVICE ENGULFED IN FLAMES AND THE TUBING BURNED UP TO THE END USER'S NECK. SHE STATED THAT SHE DID NOT BELIEVE THAT ANYONE WAS SMOKING IN THE PRESENCE OF THE DEVICE OR THERE WERE OPEN FLAMES OR CHEMICALS PRESENT HOWEVER THE END USER HAS A HISTORY OF SMOKING. THE END USER IS CURRENTLY BEING TREATED IN A HOSPITAL BURN UNIT. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, Y

  Patient problems: Burn(s)

  MAUDE report 22394157 ↗
• InjuryJul 2, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER WHO REPORTED THAT THERE WAS A FIRE RELATED EVENT WHERE THE END USER SUSTAINED 2ND DEGREE BURNS TO HIS FACE AND WAS HOSPITALIZED FOR FOUR DAYS. HE STATED THAT THERE WAS CONSTRUCTION TAKING PLACE IN THE BUILDING AND HE NOTICED AN ELECTRICAL ODOR COMING FROM THE BATHROOM. HE WENT TO INVESTIGATE AND INDICATED THERE HE DID NOT OBSERVE FLAMES OR SMOKE; HOWEVER, HE STATED THE HEAT COMING FROM THE BATHROOM CAUSED THE OXYGEN TO IGNITE NEAR HIS FACE. THE CONCENTRATOR WAS LOCATED IN A DIFFERENT ROOM FROM WHERE THE EVENT TOOK PLACE. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22384717 ↗
• MalfunctionJun 4, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A THIRD-PARTY SERVICE CENTER WHO REPORTED THE DEVICE HAD EVIDENCE OF MELTING AROUND THE BASE REAR CABINET AND COMPRESSOR BOX. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS FOUND TO HAVE THERMAL DAMAGE TO THE BASE, COMPRESSOR BOX AND THE BOTTOM OF THE FRONT AND REAR COVERS. THE UNIT WAS FOUND TO BE VERY DIRTY AND HAD A VERY MUSTY ODOR DURING OPERATION. THE INTAKE HOSE WAS DISCONNECTED FROM THE INTAKE OF THE COMPRESSOR AND THE SPRING HAD FALLEN OUT. DAMAGED SCREW BOSSES WERE OBSERVED THROUGHOUT THE UNIT. THIS DAMAGE WAS LIKELY CAUSED BY SEVERE MISHANDLING OF THE UNIT. THE USAGE LOG, WHICH INCLUDES DATA PAST THE LAST 14.7 HOURS OF OPERATION, SHOWED THAT HIGHER THAN NORMAL TEMPERATURES WERE REACHED DURING OPERATION SINCE THE INTAKE HOSE WAS DISCONNECTED FROM THE COMPRESSOR, THE COMPRESSOR WOULD HAVE DRAWN IN THE HEATED AIR WITHIN THE UNIT WHICH WOULD HAVE CAUSED THE COMPRESSOR TO OPERATE AT A HIGHER TEMPERATURE AND ELEVATE THE INTERNAL AIR TEMPERATURE OF THE UNIT. PRIOR INVESTIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141586 ↗
• MalfunctionMay 28, 2025Sparking; Sparking

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER, WHO STATED THAT THE POWER CORD IS SPARKING. UPON VISUAL EXAMINATION OF THE RETURNED UNIT, A CUT IN THE INSULATION WAS OBSERVED THAT EXPOSED THE WIRES WITHIN THE LINE CORD. THE INSTRUCTION MANUAL FOR THIS DEVICE INCLUDES WARNINGS STATING "IMPROPER USE OF THE POWER CORD AND PLUGS CAN CAUSE A BURN, FIRE OR OTHER ELECTRIC SHOCK HAZARDS. DO NOT USE THE UNIT IF THE POWER CORD IS DAMAGED. ENSURE THE MAINS POWER CORD IS FULLY INSERTED INTO THE CONCENTRATOR CONNECTOR (230 VOLT UNITS) AND THE POWER CORD PLUG IS COMPLETELY INSERTED INTO A FULLY FUNCTIONING AC WALL OUTLET. FAILURE TO DO SO MAY CAUSE AN ELECTRICAL SAFETY HAZARD." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099649 ↗
• MalfunctionMar 26, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER, WHO REPORTED THAT THE DEVICE WAS OVERHEATING. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, THE DEVICE WAS FOUND TO HAVE EVIDENCE OF THERMAL DAMAGE TO THE SIDES AND FRONT OF THE COMPRESSOR BOX. EVIDENCE OF MISHANDLING WAS PRESENT THROUGHOUT THE DEVICE, SUCH AS MULTIPLE BROKEN SCREW BOSSES, BROKEN PLASTIC ON THE COMPRESSOR BOX AND AN INOPERABLE FAN. THE INOPERABLE FAN RESULTED IN MULTIPLE HIGH GAS TEMPERATURE ERRORS DURING USE. THERE WAS NO EVIDENCE OF AN ELECTRICAL FAULT AND ALL COMPONENTS IN THE GAS PATH WERE FOUND UNDAMAGED. FUNCTIONAL TESTING OF THE DEVICE INDICATED THE DEVICE WAS OPERATIONAL AND WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE THERMAL EVENT CANNOT BE DETERMINED WITH CERTAINTY WITH THE INFORMATION AND EVIDENCE PROVIDED. PRIOR INVESTIGATIONS OF ROOT CAUSES FOR SIMILAR WARPING ISSUE HAS DETERMINED THAT THE CONDITIONS NECESSARY TO CREATE THIS TYPE OF THERMAL EVENT ARE OUTSIDE THE ACCEPTABLE OPERATING AND STORAGE CONDITIONS FOR THIS DEVICE. CONTINUAL OP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700356 ↗
• InjuryMar 26, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR VIA A PROVIDER'S VOLUNTARY MEDWATCH REPORT WHICH STATED THAT THE END USER LIT A CIGARETTE WHILE USING THE OXYGEN CONCENTRATOR. THE END USER SUSTAINED SECOND DEGREE BURNS TO THEIR FACE. THE PROVIDER WOULD NOT PROVIDE FURTHER DETAILS OF THE END USER'S CONDITION, AND THAT THE DEVICE IS NOT BEING RELEASED FOR EVALUATION. DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCA

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21700355 ↗
• MalfunctionMar 12, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER'S MOTHER WHO STATED THE NASAL CANNULA CAUGHT ON FIRE. THE END USER FELL ASLEEP, AND THE NASAL CANNULA FELL TO THE FLOOR. A FIRE IGNITED A CUSHION WHICH WAS EXTINGUISHED BY THE END USER. THE DEVICE WAS RETURNED FOR EVALUATION. THE END USER STATED THAT THE OXYGEN CONCENTRATOR DID NOT CATCH ON FIRE AND THERE WAS NO INJURY REPORTED BY THE END USER. THE OXYGEN CONCENTRATOR WAS LOCATED BESIDE AN ASHTRAY WHEN THE PROVIDER PICKED UP THE DEVICE. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586178 ↗
• InjuryMar 5, 2025Device Emits Odor; Device Emits Odor

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A LETTER FROM AN ATTORNEY, ALLEGING THE OXYGEN CONCENTRATOR WAS EMITTING A NOXIOUS SMELL CAUSING RESPIRATORY DIFFICULTIES. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE DEVICE IN COOPERATION WITH THE ATTORNEY.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 21527178 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071397. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2025 · Apr 11, 2025 · Open, Classified
  iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.