DeVilbiss 1025DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00885304022466), received between Oct 1, 2019 and Sep 10, 2026 — classified as 10 deaths, 14 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (8 reports).

3 other recalls 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718101 ↗
• DeathSep 3, 2026Fire

  Drive Medical was notified of an incident from a device provider's attorney regarding a death from an oxygen tank or oxygen concentrator allegedly causing house fire. The patient died at hospital from injuries. The cause of the fire is unknown; no allegations. 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 50589252 ↗
• MalfunctionJun 23, 2026Use of Device Problem

  DRIVE MEDICAL WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THE DEVICE HAD FIRE DAMAGE THAT WAS IN AN END USER'S HOME. 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 EXHIBITED THERMAL DAMAGE TO THE EXTERIOR OF THE DEVICE. THERE WAS NO THERMAL DAMAGE OF ANY INTERNAL COMPONENTS. THE DEVICE HAD EVIDENCE OF BEING OPERATED IN AN AREA WHERE TOBACCO WAS IN USE. THE DEVICE'S INTERNAL HOSES, GROMMET, INTAKE FILTER AND INTAKE COMPARTMENT WERE DISCOLORED AND THE DEVICE HAD A TOBACCO SMOKE ODOR WHEN IT WAS IN OPERATION. THE DEVICE WAS TESTED AND WAS FOUND TO BE OPERATIONAL AND WITHIN DESIGN SPECIFICATIONS. IT IS BELIEVED THE FIRE ORIGINATED FROM AN EXTERNAL SOURCE AND TRAVELED TO THE OUTLET PORT OF THE DEVICE VIA THE CANNULA TUBING. THE METAL OUTLET FITTING PREVENTED FIRE INGRESS TO THE DEVICE SINCE IT DOES NOT PROVIDE THE NECESSARY FUEL FOR THE FIRE TO CONTINUE UPSTREAM INTO THE INTERNAL OXYGEN GAS PATH. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599371 ↗
• InjuryMay 6, 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 SUSTAINED SECOND DEGREE BURNS TO THEIR CHEEKS, NOSE AND NOSTRILS. THE END USER HAS NO RECOLLECTION OF THE EVENT; HOWEVER, CIGARETTES AND A LIGHTER WERE LOCATED AT THEIR BEDSIDE. THE END USER WAS TRANSPORTED BY AIR TO A BURN CENTER FOR MEDICAL EVALUATION. UPON ASSESSMENT, IT WAS DETERMINED THAT THE BURNS WERE NOT SEVERE ENOUGH TO WARRANT HOSPITAL ADMISSION. THE END USER WAS TREATED WITH AN OINTMENT. 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

  Patient problems: Burn(s)

  MAUDE report 25096261 ↗
• InjuryFeb 25, 2026Use 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 WAS SMOKING WHILE USING THE DEVICE AND RECEIVED SECOND DEGREE BURNS TO THEIR LEFT NOSTRIL. 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 MINUT

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24444852 ↗
• InjuryFeb 2, 2026No Flow

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE END USER'S DAUGHTER, WHO REPORTED THAT DURING USE THE UNIT'S RED LIGHT ILLUMINATED. SHE REPORTED THAT THE UNIT WAS NOT DELIVERING OXYGEN, AND SEEMED TO BE GETTING HOT. THE END USER WAS PLACED ON A BACK-UP OXYGEN TANK SYSTEM, HOWEVER THE END USER'S OXYGEN SATURATION REMAINED LOW AND SHE HAD TO BE MANUALLY VENTILATED VIA HER TRACHEOSTOMY TUBE. THE END USER WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. THE PROVIDER OF THE OXYGEN CONCENTRATOR TESTED THE DEVICE, AND IT WAS FOUND TO BE OPERATING PROPERLY AND NO DEFECTS WERE FOUND. THE DEVICE'S USER MANUAL CONTRAINDICATIONS STATE: THE DEVICE IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. THE DRIVE DEVILBISS 10-LITER OXYGEN CONCENTRATOR MAY BE CONTRAINDICATED IN PATIENTS AT RISK OF EXPERIENCING SERIOUS ADVERSE HEALTH CONSEQUENCES RESULTING FROM A TEMPORARY LOSS OF FUNCTION. DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24240083 ↗
• DeathDec 10, 2025Mechanical Problem; Mechanical Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THE DEVICE WAS NOT PRODUCING OXYGEN AND THE END USER PASSED AWAY. THE DEVICE WAS RETURNED FOR EVALUATION, AND IT WAS DETERMINED THAT THE UNIT WAS FUNCTIONING CORRECTLY AND WITHIN SPECIFICATION (>87% OXYGEN CONCENTRATION). WHILE THE OXYGEN SENSING BOARD WAS FOUND TO BE SLIGHTLY OUT OF TOLERANCE WHEN TESTED AT 10LPM, WHICH RESULTED IN THE UNIT ALARMING FOR LOW OXYGEN EVEN THOUGH THE OXYGEN WAS WITHIN SPECIFICATION, THE LAST USAGE LOG RECORD INDICATED THAT THE FLOW HAD BEEN TURNED ABOVE 10LPM, CONTRARY TO THE DEVICE'S INSTRUCTIONS FOR USE, CAUSING THE OXYGEN CONCENTRATION TO DROP. THE MOST RECENT RECORD IN THE USAGE LOG INDICATED THAT THE FLOWRATE WAS TURNED UP TO 17.9LPM. THE DEVICE'S INSTRUCTION GUIDE STATES: "A FLOW SETTING OTHER THAN PRESCRIBED MAY AFFECT THE PATIENT THERAPY. FOR PRESCRIPTIONS OF 10 LPM, BE SURE THE BALL IS CENTERED ON THE 10-LITER LINE. THE BALL SHOULD NOT TOUCH THE RED LINE. SETTING THE FLOW HIGHER THAN 10 MAY CAUSE THE OXYGEN PURITY LEVEL TO DROP. IF THE OXYGEN PURITY FALLS BELOW THE ACCEPTABLE LEVEL: THE GREEN NORMAL OXYGEN LIGHT WILL SHUT OFF, THE YE

  Patient problems: Insufficient Information

  MAUDE report 23770050 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY A MEDWATCH FROM THE PROVIDER INVOLVING AN OXYGEN CONCENTRATOR INCIDENT WHERE THE END USER LIT A CIGARETTE WHILE HIS OXYGEN WAS RUNNING THROUGH HIS NASAL CANNULA RESULTING IN SECOND DEGREE BURNS TO THE 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 W

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23595123 ↗
• MalfunctionSep 18, 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 TO THE FRONT COVER. 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 DAMAGE PROFILE EXHIBITED TO THE EXTERIOR OF THE DEVICE AND THE LACK OF DAMAGE TO ANY OF THE INTERNAL OXYGEN CONCENTRATOR COMPONENTS, IT CAN BE CONCLUDED THAT THE THERMAL EVENT DID NOT INITIATE FROM THE OXYGEN CONCENTRATOR OR PROPAGATE THROUGH THE UNIT BY WAY OF THE OXYGEN GAS PATH. SINCE THE DAMAGE WAS CONCENTRATED TO THE FRONT OF THE UNIT, AT THE HUMIDIFIER RECESS CAVITY, IT IS BELIEVED THAT THE FIRE ORIGINATED FROM AN EXTERNAL SOURCE AND TRAVELED TO THE OUTLET PORT OF THE UNIT VIA THE CANNULA TUBING, WHICH ALSO CAUSED THE DAMAGE AT THE BOTTOM OF THE HUMIDIFIER RECESS. THIS SUGGESTS THAT THE IGNITION OCCURRED AT THE CANNULA, WHICH FURTHER SUGGESTS THAT THE PATIENT MAY HAVE BEEN SMOKING. THE METAL OUTLET FITTING IS DESIGNED TO PREVENT FIRE INGRESS TO THE DEVICE. THE METAL OUTLET FITTING ACTS AS A FIRE BREAK, DESIGNED TO PREVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084780 ↗
• MalfunctionSep 12, 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 THERMAL DAMAGE TO THE DEVICE. 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 DAMAGE PROFILE EXHIBITED TO THE EXTERIOR OF THE DEVICE AND THE LACK OF DAMAGE TO ANY OF THE INTERNAL OXYGEN CONCENTRATOR COMPONENTS, DEMONSTRATED THAT THE THERMAL EVENT DID NOT INITIATE FROM THE OXYGEN CONCENTRATOR OR PROPAGATE THROUGH THE UNIT BY WAY OF THE OXYGEN GAS PATH. SINCE THE DAMAGE WAS CONCENTRATED TO THE FRONT OF THE UNIT, AT THE HUMIDIFIER RECESS CAVITY, IT IS BELIEVED THAT THE FIRE ORIGINATED FROM AN EXTERNAL SOURCE AND TRAVELED TO THE OUTLET PORT OF THE UNIT VIA THE CANNULA TUBING. THIS SUGGESTS THAT THE IGNITION OCCURRED AT THE CANNULA, WHICH FURTHER SUGGESTS THAT THE PATIENT MAY HAVE BEEN SMOKING. THE METAL OUTLET FITTING IS DESIGNED TO PREVENT FIRE INGRESS TO THE DEVICE SINCE IT DOES NOT PROVIDE THE NECESSARY FUEL FOR THE FIRE TO CONTINUE UPSTREAM INTO THE INTERNAL OXYGEN GAS PATH. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037784 ↗
• InjuryAug 27, 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 WAS SMOKING WHILE USING THE OXYGEN CONCENTRATOR. THE END USER SUSTAINED SECOND DEGREE BURNS TO THEIR HANDS AND FACE. THE END USER DECLINED HOSPITALIZATION. THE END USER HAS BEEN REPEATEDLY EDUCATED ON OXYGEN SAFETY. 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 ROO

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22905529 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Mechanical Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO STATED THAT THE OXYGEN CONCENTRATOR WAS "SHOOTING OUT FIRE" FROM THE VENTS ON THE BOTTOM OF THE DEVICE. THIS OCCURRED AFTER A ROUTINE FILTER CHANGE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE PROVIDER REPORTED THE DEVICE WAS OPERATING IN A DUSTY AND TAR FILLED SMOKER HOME. THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, THE MANUFACTURER FOUND THE WIRE HARNESS TO BE SEVERED. IT IS LIKELY THAT THE WIRE HARNESS WAS NOT PROPERLY TUCKED AT THE REAR OF THE UNIT OR WAS DISLODGED DURING A SHARP IMPACT, WHICH ALLOWED IT TO RUB AGAINST THE COMPRESSOR BRACKETS. OVER TIME THIS FRICTION WORE THROUGH THE CONVOLUTED TUBING AND EVENTUALLY THE BLACK AND WHITE WIRES. IT IS LIKELY THAT ARCING OCCURRED AS THE BLACK AND WHITE WIRES CONTACTED THE METAL COMPRESSOR BRACKET. HOWEVER, NO EVIDENCE OF THE UNIT SHOOTING OUT FIRE FROM THE GRATES' WAS OBSERVED AS THE FOAM AND BASE SHOWED NO EVIDENCE OF THERMAL DAMAGE OR CHARRING FROM FLAMES OR SPARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851584 ↗
• InjuryAug 14, 2025Fire; Fire

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED AN APARTMENT FIRE INVOLVING HOME OXYGEN. THE END USER STATED THE UNIT MADE LOUD NOISES AND EXPLODED. HOWEVER, PUBLIC REPORTS OF THE FIRE INDICATE THAT THE END USER IS AN ACTIVE SMOKER. THE PROVIDER INDICATED THAT THE END USER HAS BEEN EDUCATED MULTIPLE TIMES ON THE DANGERS OF SMOKING WHILE ON OXYGEN. PUBLIC REPORTS ALSO INDICATE THERE MAY HAVE BEEN BURN VICTIMS AT THE SCENE. 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 LO

  Patient problems: Burn(s)

  MAUDE report 22806952 ↗
• DeathJul 23, 2025Device Emits Odor; Powder Leak; Device Emits Odor; Powder Leak

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY AN ATTORNEY, WHO ALLEGED THAT THE DEVICE EXPLODED AND RELEASED A YELLOWISH POWDER AND AN INTENSE NOXIOUS ODOR. THE END USER ALLEGEDLY SUFFERED IMMEDIATE RESPIRATORY DISTRESS AND DIED SHORTLY AFTER. A REVIEW OF OUR RECORDS INDICATED THAT A DIFFERENT END USER REPORTED THE SAME DEVICE AS ALARMING A MONTH PRIOR TO THIS EVENT, AS A RESULT OF WHICH IT WAS RETURNED TO THE DME PROVIDER FOR SERVICE. IT IS UNCLEAR AT THIS TIME WHAT SERVICE WAS PERFORMED ON THE DEVICE AT THAT TIME. DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ARRANGING AN INSPECTION OF THE DEVICE THROUGH THE ATTORNEY. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Aspiration Pneumonitis

  MAUDE report 22576408 ↗
• MalfunctionJun 11, 2025Fire; Melted; Fire; Melted

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER, WHO STATED THAT "THE POWER CORD CAUGHT FIRE, BURNED AND MELTED." EVALUATION OF THE DEVICE BY DEVILBISS DETERMINED THAT THE LINE CORD'S INTERNAL WIRING AND CRIMP WERE BOTH INTACT. THE DAMAGE TO THE PRONG AND PLUG APPEARS TO BE A RESULT OF A POOR ELECTRICAL CONNECTION BETWEEN THE PRONG AND THE OUTLET RECEPTACLE. SUCH A CONNECTION WOULD GENERATE INCREASED ELECTRICAL RESISTANCE, SUBSEQUENTLY CAUSING THE PRONG TO OVERHEAT. 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 22184386 ↗
• MalfunctionApr 2, 2025Thermal Decomposition of Device; Use of Device Problem; Thermal Decomposition of Device; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A THIRD-PARTY SERVICE CENTER WHO REPORTED THE DEVICE WAS DAMAGED BY A FIRE, HAVING EVIDENCE OF A BURNT FRONT COVER. 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 DAMAGE TO THE UNIT IS CONCENTRATED TO THE FRONT OF THE UNIT, AT THE HUMIDIFIER RECESS CAVITY. THE THERMAL EVENT APPEARS TO HAVE STARTED EXTERNAL TO THE DEVICE CAUSING CHARRING ON THE BACK, SIDE, AND BOTTOM OF THE HUMIDIFIER RECESS. THE METAL OUTLET APPEARS TO HAVE PREVENTED FIRE INGRESS TO THE UNIT. THE DAMAGE TO THE BOTTOM OF THE HUMIDIFIER CAVITY AND CHARRED PIECES FOUND THERE, WAS LIKELY CAUSED BY THE CANNULA HANGING DOWN FROM THE PLASTIC FITTING THAT WAS CONNECTED TO THE OUTLET PORT. ALL INTERNAL COMPONENTS WITHIN THE GAS PATH WERE FOUND TO BE UNDAMAGED. FUNCTIONAL TESTING OF THE UNIT INDICATED THAT IT WAS OPERATIONAL AND WITHIN SPECIFICATION (>87% OXYGEN CONCENTRATION) AT BOTH 5 AND 10LPM FLOW SETTINGS. THE FAN AND ALARM SYSTEM WERE BOTH FOUND TO BE FUNCTIONAL. AN ODOR OF CIGARETTE SMOKE WAS COMING FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756307 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A SUMMONS FROM AN ATTORNEY, ALLEGING AN OXYGEN CONCENTRATOR WAS PRESENT AT A FIRE SCENE. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS IN THE ADJACENT ROOM TO THE FIRE. THE END USER SUSTAINED BURNS TO THEIR LEGS AND ARMS, REQUIRING AMPUTATION. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE ISSUE.

  Patient problems: Burn(s)

  MAUDE report 21527179 ↗
• InjuryJan 8, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THAT THE END USER WAS OPERATING A METAL GRINDER. THE END USER WAS USING THEIR OXYGEN CONCENTRATOR VIA NASAL CANNULA AT THE TIME OF THE INCIDENT AND A SPARK CAME FROM THE METAL GRINDER AND IGNITED THE OXYGEN COMING FROM THE NASAL CANNULA. THE END USER SUSTAINED SECOND DEGREE BURNS TO THEIR CHEEK, UPPER LIP, NOSE AND NARES. THE END USER WAS PRESCRIBED SILVADENE CREAM AND PAIN MEDICATION. THERE WAS NO REPORT OF DEVICE MALFUNCTION. 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

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 21107081 ↗
• InjuryDec 4, 2024Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THAT THE END USER WAS SMOKING A CIGARETTE WHILE USING THE DEVICE. THE END USER RECEIVED THIRD DEGREE BURNS TO THEIR NOSE, NOSTRILS, UPPER AND LOWER LIPS, CHEEKS AND CHIN AREA. 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 T

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 20844331 ↗
• DeathOct 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A LETTER FROM AN ATTORNEY, ALLEGING THE DEVICE WAS DEFECTIVE AND THE END USER PASSED AWAY. (B)(6) HEALTHCARE IS IN THE PROCESS OF REQUESTING THE UNIT BE RETURNED FOR EVALUATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20465663 ↗
• MalfunctionJul 24, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A PROVIDER WHO REPORTED THE DEVICE HAD MELTED PLASTIC ON THE INSIDE DUE TO OVERHEATING. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE HAS REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818547 ↗
• MalfunctionJul 11, 2024Thermal 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 STATED THAT THE COMPRESSOR HEATS UP. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE THIRD-PARTY SERVICE CENTER EVALUATED THE DEVICE AND FOUND EVIDENCE OF THERMAL DAMAGE TO THE PLASTIC FRAME THAT THE SIEVE BED AND MAIN CIRCUIT BOARD WERE MOUNTED TO. THE THIRD-PARTY SERVICE CENTER REPLACED THE PLASTIC HOUSING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721915 ↗
• InjuryMay 30, 2024Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR WHEN IT RECEIVED MEDWATCH REPORT 261616-2024-0001, WHICH STATED THAT "CAREGIVER REPORTED FIRE CAUSED BY ELECTRIC OUTLET HOWEVER BECAUSE OF THE PATIENT'S HISTORY OF SMOKING, NON-COMPLIANCE WITH SAFETY INTERVENTIONS, LOCATION OF BURNS, AND THE FACT THE WINDOWS BLEW OUT WE BELIEVE THAT PERHAPS THE PT TOOK THE OXYGEN OFF AND PUT IT UNDER HER BOTTOM TO SMOKE AND DID NOT TURN OFF THE OXYGEN. FIRE DEPARTMENT REPORTS ARE CURRENTLY UNAVAILABLE." THE FIRE DEPARTMENT REPORTEDLY DISPOSED OF THE CONCENTRATOR. DEVILBISS HEALTHCARE HAS REQUESTED THAT THE FIRE DEPARTMENT PROVIDE A COPY OF THE FIRE REPORT. DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 19427774 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVILBISS HEALTHCARE RECEIVED A MEDWATCH REPORT ((B)(4)) STATING THAT AN OXYGEN CONCENTRATOR WAS IN USE AT 10 LPM WHEN THE END USER LIT A CIGARETTE, SUSTAINED BURNS ON HIS RIGHT UPPER ARM, A SIX-INCH BLISTER ON HIS RIGHT FOREARM, MULTIPLE BURNS ON HIS CHEST, BILATERAL FLANKS AND ABDOMEN AND BURNED HAIR ON HIS BEARD. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN THE 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 C

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 19209349 ↗
• DeathApr 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT ALLEGEDLY INVOLVING AN OXYGEN CONCENTRATOR BY A LETTER FROM AN ATTORNEY, WHICH STATES THE OXYGEN CONCENTRATOR MALFUNCTIONED WHILE IN USE AND THE END USER PASSED AWAY. THE END USER SUFFERED FROM SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE DEVICE IN COOPERATION WITH THE ATTORNEY.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 19082200 ↗

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.
• Z-1558-2023 · Mar 9, 2023 · Open, Classified
  DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
• Z-0724-2023 · Nov 18, 2022 · Open, Classified
  DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q