INVACARE® PERFECTO2¿ OXYGEN CONCENTRATOR
Report
- Report Number
- 3013095415-2025-00853
- Event Type
- Injury
- Date Received
- September 30, 2025
- Date of Event
- July 13, 2025
- Report Date
- September 30, 2025
- Manufacturer
- INVACARE FLORIDA
- Product Code
- CAW
- PMA / PMN Number
- K200890
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001: SECTION E4, INITIAL REPORTER ALSO SENT REPORT TO THE FDA, OF THE INITIAL MEDWATCH REPORT STATED: UNKNOWN. SECTION E4, INITIAL REPORTER ALSO SENT REPORT TO THE FDA, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: NO. NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001: H6: ON DECEMBER 1, 2025, VENTEC RECEIVED ADDITIONAL INFORMATION FROM THE DEVICE'S PREVIOUS MANUFACTURER, INVACARE, REGARDING THE INVACARE® PERFECTO2V OXYGEN CONCENTRATOR INVOLVED IN THE (B)(6) FIRE. THE FDA HAD SUBMITTED AN EMAIL REQUEST FOR ADDITIONAL INFORMATION TO INVACARE. (B)(6), FDA GENERAL ENGINEER, ASKED INVACARE: ¿YOUR DOCUMENTATION STATED THE DEVICE OF CONCERN IN THE REPORTED FIRE IS NO LONGER MANUFACTURED, AND ANOTHER COMPANY HAS ACQUIRED INVACARE¿S RESPIRATORY DEVICES BUSINESS (REACT HEALTH/VENTEC) AS OF EARLY 2023. HOWEVER, I¿M INTERESTED TO UNDERSTAND WHETHER THE DEVICE OF CONCERN WAS APPROPRIATELY DESIGNED AND TESTED FOR FIRE PREVENTION, PER CLAUSES 201.11.3.101 AND 201.102.3 OF ISO 80601-2-69. COULD YOU CITE TESTING RELEVANT TO THESE CLAUSES FOR THE DEVICE OF CONCERN?¿ INVACARE RESPONDED, STATING: ¿WE RECEIVED YOUR EMAIL TODAY REGARDING THE DESIGN AND FIRE PREVENTION TESTING OF THE INVACARE® PERFECTO2V OXYGEN CONCENTRATOR. THE DEVICE WAS ORIGINALLY APPROPRIATELY DESIGNED TO MEET THE FIRE PREVENTION REQUIREMENTS DEFINED WITHIN THE ISO 80601-2-69 MEDICAL ELECTRICAL EQUIPMENT ¿ PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT INTERNATIONAL STANDARD, FIRST EDITION 2014-07-15. THE DEVICE WAS TESTED BY INTERTEK TESTING SERVICES, NA, INC FOR FIRE PREVENTION TESTING IN ACCORDANCE WITH CLAUSE 201.11.2.101 AND FIRE RISK REDUCTION IN ACCESSORIES IN ACCORDANCE WITH CLAUSE 201.102.3 OF THE ISO 80601-2-69 STANDARD, REPORT NUMBER: 102196296MIN-003, DATE OF ISSUE: JULY 14, 2016. THE TEST RESULTS CONFIRMED THAT THE DEVICE MET ALL APPLICABLE ACCEPTANCE CRITERIA. A COPY OF THE TEST REPORT IS INCLUDED FOR YOUR REFERENCE. PLEASE NOTE THAT THE ADDITIONAL REQUIREMENTS FOR FIRE ENCLOSURES OF ME EQUIPMENT, CLAUSE 201.11.3.101 WAS NOT INCLUDED IN THE ISO 80601-2-69 STANDARD AT THE TIME OF TESTING ON JULY 14, 2016. THIS REQUIREMENT WAS ADDED IN THE SECOND EDITION OF THE STANDARD PUBLISHED IN NOVEMBER 2020. THE SERIAL NUMBER ((B)(6)) REFERENCED IN THE MDR FILED BY REACT WAS MANUFACTURED PRIOR TO NOVEMBER 2020.¿ INVACARE HAS YET TO PROVIDE VENTEC WITH THEIR COMPLETED INVESTIGATION REPORT. ONCE RECEIVED, VENTEC WILL SUBMIT A FOLLOW-UP REPORT AS DEFINED BY 21 CFR 803.56.
CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 -- SECTION E4, INITIAL REPORTER ALSO SENT REPORT TO THE FDA, OF THE INITIAL MEDWATCH REPORT STATED: UNKNOWN. SECTION E4, INITIAL REPORTER ALSO SENT REPORT TO THE FDA, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: NO. NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 -- H6: VENTEC REVIEWED THE PUBLICLY AVAILABLE ¿(B)(6) FIRE AFTER ACTION REPORT¿, RELEASED BY THE (B)(6) WHICH STATED THE FOLLOWING [P.11]: ¿INVESTIGATORS FOUND NO EVIDENCE OF INTENTIONAL IGNITION. THERE WERE NO INDICATIONS THAT COOKING EQUIPMENT, HEATING APPLIANCES, LIGHTING, ELECTRICAL OUTLETS, OR OTHER APPLIANCES CAUSED IGNITION. NO CANDLES, INCENSE, OR RELATED ITEMS WERE IDENTIFIED. THE DAMAGED REMAINS OF A BATTERY-POWERED SCOOTER WERE RECOVERED AND EXAMINED; BATTERY FAILURE WAS RULED OUT AS A CONTRIBUTING FACTOR. AN OXYGEN CONCENTRATOR AND MULTIPLE SMOKING MATERIALS WERE LOCATED IN THE ROOM OF ORIGIN. INVESTIGATORS DEVELOPED IGNITION HYPOTHESES INVOLVING BOTH ITEMS. DUE TO THE EXTENT OF THE DAMAGE AND THE LOSS OF THE ROOM¿S OCCUPANT, INVESTIGATORS WERE UNABLE TO CONFIRM OR RULE OUT AN ELECTRICAL OR MECHANICAL FAILURE INVOLVING THE CONCENTRATOR OR THE IMPROPER USE OR DISPOSAL OF SMOKING MATERIALS. THE OFFICIAL CLASSIFICATION OF FIRE CAUSE IS UNDETERMINED WITH TWO POSSIBLE ACCIDENTAL IGNITION SOURCES: SMOKING MATERIALS OR AN OXYGEN CONCENTRATOR FAILURE. REGARDLESS OF IGNITION SOURCE, THE PRESENCE OF MEDICAL OXYGEN IN THE ROOM OF ORIGIN AND OTHER ROOMS THROUGHOUT THE FACILITY WAS IDENTIFIED AS A SIGNIFICANT FACTOR IN THE RAPID-FIRE GROWTH AND SPREAD. OXYGEN-ENRICHED ENVIRONMENTS ALLOW FOR EASIER IGNITION, HIGHER BURN TEMPERATURES, AND ACCELERATED FIRE DEVELOPMENT.¿ ADDITIONALLY, PREVIOUS MEDIA REPORTS SUGGESTED THAT WHILE SMOKING INDOORS AT THE (B)(6) WAS NOT PERMITTED, RESIDENTS AT THE FACILITY WERE KNOWN TO SMOKE IN THEIR ROOMS. THIS ALIGNS WITH THE EVIDENCE IN THE (B)(6) REPORT PRESENTED ABOVE. (NYT, ¿SPECULATION SWIRLS AFTER DEADLY FIRE AT (B)(6) ASSISTED LIVING FACILITY¿, (B)(6) 2025). (B)(6). A LAWSUIT BROUGHT FORTH BY THE SURVIVORS ALSO ALLEGED THAT THE (B)(6) FAILED TO ¿¿MEANINGFULLY ENFORCE ITS NO-SMOKING POLICY.¿ (B)(6) SUES (B)(6) ON BEHALF OF FIRE SURVIVORS¿, (B)(6), ATTORNEY AT (B)(6), 8/01/2025). (B)(6). THERE ARE SEVERAL CLEAR AND UNAMBIGUOUS WARNINGS FOUND IN THE INVACARE® HOMEFILL® OXYGEN SYSTEM USER MANUAL ABOUT THE DANGER OF SMOKING WHILE ON OR NEAR THE HOMEFILL® DEVICE: "DANGER! RISK OF DEATH, INJURY, OR DAMAGE FROM FIRE TEXTILES, OIL OR PETROLEUM SUBSTANCES, GREASE, GREASY SUBSTANCES AND OTHER COMBUSTIBLES ARE EASILY IGNITED AND BURN WITH GREAT INTENSITY IN OXYGEN ENRICHED AIR AND WHEN IN CONTACT WITH OXYGEN UNDER PRESSURE. TO AVOID FIRE, DEATH, INJURY OR DAMAGE: DO NOT SMOKE WHILE USING THIS PRODUCT. DO NOT USE NEAR OPEN FLAME OR IGNITION SOURCES. DO NOT USE ANY LUBRICANTS ON THE CYLINDER UNLESS RECOMMENDED BY INVACARE. NO SMOKING SIGNS SHOULD BE PROMINENTLY DISPLAYED. AVOID CREATION OF ANY SPARK NEAR OXYGEN EQUIPMENT. THIS INCLUDES SPARKS FROM STATIC ELECTRICITY CREATED BY ANY TYPE OF FRICTION. KEEP ALL MATCHES, LIGHTED CIGARETTES, ELECTRONIC CIGARETTES OR OTHER SOURCES OF IGNITION OUT OF THE ROOM IN WHICH THIS CYLINDER IS LOCATED AND AWAY FROM WHERE OXYGEN IS BEING DELIVERED. KEEP THE OXYGEN TUBING, CORD, AND CYLINDER OUT FROM UNDER SUCH ITEMS AS BLANKETS, BED COVERINGS, CHAIR CUSHIONS, CLOTHING, AND AWAY FROM HEATED OR HOT SURFACES INCLUDING SPACE HEATERS, STOVES, AND SIMILAR ELECTRICAL APPLIANCES." [P.8] ¿DANGER! RISK OF DEATH, INJURY, OR DAMAGE FROM FIRE TEXTILES, OIL OR PETROLEUM SUBSTANCES, GREASE, GREASY SUBSTANCES AND OTHER COMBUSTIBLES ARE EASILY IGNITED AND BURN WITH GREAT INTENSITY IN OXYGEN-ENRICHED AIR AND WHEN IN CONTACT WITH OXYGEN UNDER PRESSURE. TO AVOID FIRE, DEATH, INJURY OR DAMAGE: DO NOT SMOKE WHILE USING THIS DEVICE. - DO NOT USE NEAR OPEN FLAME OR IGNITION SOURCES. DO NOT USE ANY LUBRICANTS ON THE COMPRESSOR UNLESS RECOMMENDED BY INVACARE. NO SMOKING SIGNS SHOULD BE PROMINENTLY DISPLAYED. AVOID CREATION OF ANY SPARK NEAR OXYGEN EQUIPMENT. THIS INCLUDES SPARKS FROM STATIC ELECTRICITY CREATED BY ANY TYPE OF FRICTION. KEEP ALL MATCHES, LIGHTED CIGARETTES OR OTHER SOURCES OF IGNITION OUT OF THE ROOM IN WHICH THIS COMPRESSOR IS LOCATED AND AWAY FROM WHERE OXYGEN IS BEING DELIVERED. KEEP THE OXYGEN TUBING, CORD, AND COMPRESSOR OUT FROM UNDER SUCH ITEMS AS BLANKETS, BED COVERINGS, CHAIR CUSHIONS, AND CLOTHING AND AWAY FROM HEATED OR HOT SURFACES, INCLUDING SPACE HEATERS, STOVES AND SIMILAR ELECTRICAL APPLIANCES.¿ [P.14] THERE ARE ALSO WARNING LABELS AFFIXED TO THE HOMEFILL® ADVISING "DO NOT SMOKE" AND "NO OPEN FLAME". [P.4] VENTEC REACHED OUT TO THE PREVIOUS DEVICE MANUFACTURER, INVACARE, FOR AN UPDATE ON THEIR INVESTIGATION. VENTEC WAS ADVISED THAT THERE WERE TWO SITE INSPECTIONS AT (B)(6) WHICH TOOK PLACE ON 10/27/2025 AND 10/28/2025, SPECIFICALLY CONCERNING THE COLLECTION, EXAMINATION AND PHOTOGRAPHING THE IDENTIFIED SPRINKLER HEADS AND PIPING FROM THE FIRE SCENE. THESE SITE INSPECTIONS DID NOT INVOLVE OR INCLUDE THE INVACARE® PERFECTO 2¿ V OXYGEN CONCENTRATOR, HOMEFILL®, OR ANY OF THE EVIDENCE REMOVED FROM THE ROOM OF FIRE ORIGIN. INVACARE¿S INVESTIGATION TEAM ADVISED THE FOLLOWING: ¿OUR PRELIMINARY FINDINGS INDICATE THAT THERE WAS FIRE ATTACK TO THE O2 CONCENTRATOR CORD AND ARCHING ON THE OUTSIDE. THE O2 CONCENTRATOR WAS RUNNING AND PROPERLY FUNCTIONING BUT THE FIRE ATTACK CAUSED ARCHING ON THE OUTSIDE. IF THE CONCENTRATOR IS PROPERLY OPERATING AND THEN ATTACKED BY FIRE, THE POSITIVE AND NEGATIVE CONDUCTORS WILL HAVE AN ARCHING EVENT ON THE OUTSIDE WHICH IS EVIDENCE OF FIRE ATTACKING THE CONCENTRATOR CAUSING IT TO STOP FUNCTIONING ¿ WHICH IS WHAT THE EVIDENCE TO DATE INDICATES.¿ THE INVESTIGATION TEAM FURTHER ADVISED THAT THEY WANT TO X-RAY WHAT REMAINS OF THE INVACARE® PERFECTO 2¿ V OXYGEN CONCENTRATOR, HOWEVER, THERE IS NOT MUCH LEFT, AND IT HAS NOT BEEN RELEASED BY AUTHORITIES FOR EXAMINATION. FURTHERMORE, THE INVESTIGATION TEAM ADVISED THAT THE SPRINKLER HEADS ARE THE MAIN POINT OF CONTENTION BECAUSE THE (B)(6) FIRE SUPPRESSION SYSTEM DID NOT ACTIVATE AND/OR HAVE WATER FLOW. THE SPRINKLER HEADS WERE MANUFACTURED BY CENTRAL SPRINKLER COMPANY BEGINNING IN THE MID-1970S THROUGH 2001. THERE WAS A VOLUNTARY RECALL INVOLVING THE SPRINKLER HEADS IN 2001 DUE TO POTENTIAL ISSUES WITH THE RUBBER O-RING SEALS THAT COULD CAUSE THE SPRINKLER HEADS NOT TO ACTIVATE DURING A FIRE. THE UNDENIABLE EVIDENCE IS THAT (B)(6) NEVER REPLACED THE DEFECTIVE SPRINKLER HEADS. INVACARE¿S LEGAL COUNSEL ADVISED VENTEC THAT THE (B)(6) SUPERIOR COURT HAS CONSOLIDATED ALL OF THE CURRENT CASES, AND THAT INVACARE HAS NOT BEEN ADDED AS A PARTY DEFENDANT. TO DATE, THE PARTIES INVOLVED HAVE NOT SCHEDULED A LAB INSPECTION/EXAMINATION OF THE ORIGIN AND CAUSE (O&C) EVIDENCE INCLUDING THE INVACARE® PERFECTO 2¿ V OXYGEN CONCENTRATOR AND HOMEFILL® DEVICES. IN THE EVENT THAT VENTEC IS PROVIDED WITH ADDITIONAL INFORMATION ABOUT THIS INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS DEFINED BY 21 CFR 803.56. THE CAUSE OF THE (B)(6) FIRE HAS NOT BEEN CONCLUSIVELY DETERMINED.
H6: VENTEC HAS DETERMINED THAT THIS DEVICE WAS PLACED INTO COMMERCIAL DISTRIBUTION BACK IN FEBRUARY OF 2015, WHICH PREDATES THE REQUIRED UDI COMPLIANCE DATE FOR CLASS II MEDICAL DEVICES. AS A RESULT, NO UDI# EXISTS FOR THIS DEVICE AND SECTION D4, UDI#, SHALL STATE ¿NONE.¿ THE DEVICE HAS NOT BEEN RETURNED TO INVACARE OR VENTEC (REACT HEALTH) FOR AN EVALUATION. INVACARE CONTINUES TO INVESTIGATE THE REPORTED ISSUE. ONCE COMPLETE, VENTEC WILL BE PROVIDED WITH THEIR INVESTIGATION FINDINGS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.
THE DEVICE¿S PREVIOUS MANUFACTURER, INVACARE, CONTACTED VENTEC VIA EMAIL TO REPORT THAT THEIR LEGAL DEPARTMENT HAD RECEIVED A LETTER FROM A LAW FIRM WHICH STATED THE FOLLOWING: ¿TO WHOM IT MAY CONCERN, THIS LAW FIRM HAS BEEN RETAINED BY (B(6) TO REPRESENT ITS SUBROGATION INTERESTS ARISING FROM A FIRE ON (B)(6) 2025, AT (B)(6) (THE ¿PROPERTY¿). (B)(6) PROVIDES PROPERTY INSURANCE TO (B)(6) FOR ITS INTERESTS AT THE PROPERTY. OUR INVESTIGATION INTO THE FIRE IS UNDERWAY. WITHIN THE ROOM OF THE FIRE ORIGIN, WE LOCATED THE FOLLOWING PRODUCTS MANUFACTURED AND/OR DISTRIBUTED BY YOUR COMPANY: - INVACARE O2 HOMEFILL II COMPRESSOR (MODEL: IOH200) - INVACARE PERFECTO 2 V OXYGEN CONCENTRATOR (MODEL: IRC5PO2V / SERIAL: (B)(6)¿ [THE SERIAL NUMBER FOR THE INVACARE O2 HOMEFILL II COMPRESSOR IS CURRENTLY UNKNOWN]. THEN ON 09/03/2025 2025, VENTEC RECEIVED ADDITIONAL INFORMATION FROM INVACARE, WHICH INCLUDED A COPY OF A LAWSUIT FILED AGAINST (B)(6) REGARDING A RESIDENT WHO WAS INJURED IN THE FIRE. FOR PRIVACY, THE RESIDENT SHALL BE IDENTIFIED AS (B)(6)¿. THE LAWSUIT STATED THE FOLLOWING: (B)(6) IS A 73-YEAR-OLD DOUBLE AMPUTEE WITH A LEFT-HAND DEFECT FROM BIRTH, WHO RESIDED ON THE SECOND (B)(6) FOR APPROXIMATELY 8 YEARS, AND REQUIRED A MOTORIZED WHEELCHAIR TO GET AROUND.¿ ¿ON THE DATE OF THE FIRE, THE PLAINTIFF, (B)(6), ALLEGED THAT HE WAS TRAPPED IN HIS ROOM AS THE SECOND FLOOR FILLED WITH SMOKE. THE WINDOW IN HIS ROOM WAS BLOCKED BY THE AIR CONDITIONING UNIT, SUCH THAT THE FIRST RESPONDERS COULD NOT GET HIM OUT THROUGH IT BUT HAD TO REMOVE PIECES OF WOOD AROUND A BATHROOM WINDOW TO PULL HIM OUT AND CARRY HIM DOWN A LADDER. IN THE PROCESS OF HIS RESCUE, HIS PROSTHETIC LEG FELL OFF.¿ (B)(6) SURVIVED THE FIRE ON (B)(6) 2025 BUT WAS INJURED AND TAKEN TO THE HOSPITAL. THE LAWSUIT FURTHER ALLEGED THAT (B)(6) EXPERIENCED SIGNIFICANT EMOTIONAL DISTRESS AND HAS ¿SUFFERED GREAT PAIN OF BODY AND MIND.¿ THIS MEDWATCH REPORT IS TO DOCUMENT THE INJURY OF PATIENT (B)(6) AS IT PERTAINS TO THE INVACARE® PERFECTO2¿ OXYGEN CONCENTRATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23339 | INVACARE® PERFECTO2¿ OXYGEN CONCENTRATOR | GENERATOR, OXYGEN, PORTABLE | CAW | INVACARE FLORIDA | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Life Threatening| H |