BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE® PERFECTO2¿ OXYGEN CONCENTRATOR

    MDR report key: 22919349 · Received August 28, 2025

    Report

    Report Number
    3013095415-2025-00773
    Event Type
    Death
    Date Received
    August 28, 2025
    Date of Event
    July 13, 2025
    Report Date
    August 28, 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

    Additional Manufacturer Narrative · 0

    H6: VENTEC REVIEWED THE PUBLICLY AVAILABLE ¿(B)(6) FIRE AFTER ACTION REPORT¿, RELEASED BY THE (B)(6) FIRE DEPARTMENT 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¿, 7/15/2025: (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). THE INVACARE® PERFECTO 2¿ V OXYGEN CONCENTRATOR USER MANUAL PROVIDES MULTIPLE WARNINGS ABOUT THE DANGERS ASSOCIATED WITH USING THE OXYGEN CONCENTRATOR NEAR A FLAME, INCLUDING (BUT NOT LIMITED TO) THE FOLLOWING: ¿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. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN BURNS OR DEATH. TO AVOID FIRE, DEATH, INJURY OR DAMAGE: DO NOT SMOKE WHILE USING THIS DEVICE. - DO NOT USE NEAR OPEN FLAM OR IGNITION SOURCES. NO SMOKING SIGNS SHOULD BE PROMINENTLY DISPLAYED. KEEP ALL OPEN FLAMES, MATCHES, LIGHTED CIGARETTES, ELECTRONIC CIGARETTES OR OTHER SOURCES OF IGNITION AT LEAST 10 FT (3M) AWAY FROM THIS CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES SUCH AS CANNULAS OR TANKS." [P. 9] ¿DANGER! RISK OF DEATH, INJURY OR DAMAGE FROM FIRE TEXTILES, OIL OR PETROLEUM SUBSTANCES AND OTHER COMBUSTIBLES ARE EASILY IGNITED AND BURN WITH GREAT INTENSITY IN OXYGEN ENRICHED AIR AND WHEN IN CONTACT WITH OXYGEN UNDER PRESSURE. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN BURNS OR DEATH. TO AVOID FIRE, DEATH, INJURY OR DAMAGE: - DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR OXYGEN CARRYING ACCESSORIES ARE LOCATED. - IF YOU DISREGARD THESE WARNINGS ABOUT THE SEVERE HAZARD OF OXYGEN USE WHILE YOU CONTINUE TO SMOKE, YOU MUST ALWAYS TURN OFF THE CONCENTRATOR, REMOVE THE CANNULA AND THEN WAIT 10 MINUTES BEFORE SMOKING OR LEAVE THE ROOM WHERE EITHER THE CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES SUCH AS CANNULAS OR TANKS ARE LOCATED." [P. 10] THE INVACARE® PERFECTO 2¿ V OXYGEN CONCENTRATOR ALSO HAS THE FOLLOWING TWO (2) LABELS AFFIXED TO THE FRONT OF THE DEVICE: "DANGER RISK OF FIRE - NO SMOKING, OPEN FLAME OR IGNITION SOURCES KEEP ALL SOURCES OF IGNITION OUT OF THE ROOM IN WHICH THIS PRODUCT IS LOCATED AND AWAY FROM AREAS WHERE OXYGEN IS BEING DELIVERED. TEXTILES, OIL AND OTHER COMBUSTIBLES ARE EASILY IGNITED AN BURN WITH GREAT INTENSITY IN OXYGEN ENRICHED AIR." [P. 8] "NO SMOKING" [P. 8] 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 O2 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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001: SECTION E1, REPORTER FIRST NAME, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER FIRST NAME, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER LAST NAME, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER LAST NAME, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER FACILITY NAME, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER FACILITY NAME, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER ADDRESS 1, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER STREET ADDRESS, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER ADDRESS 2, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER ADDRESS 2, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: BLANK. SECTION E1, REPORTER CITY, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER CITY, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER STATE, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER STATE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER POSTAL CODE, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER POSTAL CODE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER EMAIL, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER EMAIL, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER PHONE, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER PHONE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: (B)(6). SECTION E1, REPORTER FAX, OF THE INITIAL MEDWATCH REPORT STATED: (B)(6). SECTION E1, REPORTER FAX, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: BLANK. 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. SECTION G2, REPORT SOURCE, OF THE INITIAL MEDWATCH REPORT STATED: CONSUMER. SECTION G2, REPORT SOURCE, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE STATED: OTHER, PREVIOUS DEVICE MANUFACTURER. 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)(4), 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 (B)(4) 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: (B)(4), 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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]. THE INVACARE LEGAL DEPARTMENT THEN COMPLETED SOME RESEARCH REGARDING THE ¿(B)(6)¿ FIRE. THROUGH THIS RESEARCH, INVACARE BECAME AWARE THAT 10 PEOPLE HAD DIED AS A RESULT OF THE FIRE. THIS MEDWATCH REPORT IS TO DOCUMENT THE DEATH OF PATIENT ¿(B)(6)¿ AS IT PERTAINS TO THE INVACARE® PERFECTO2¿ OXYGEN CONCENTRATOR. NO FURTHER DETAILS ABOUT THE PATIENT OR THEIR CAUSE OF DEATH WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075356 INVACARE® PERFECTO2¿ OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death