BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFECTO2V OXYGEN CONCENTRATOR

    MDR report key: 19316002 · Received May 14, 2024

    Report

    Report Number
    3013095415-2024-00392
    Event Type
    Death
    Date Received
    May 14, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 16, 2024
    Manufacturer
    INVACARE FLORIDA
    Product Code
    CAW
    PMA / PMN Number
    K200890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H6: SECTION H6, HEALTH EFFECT - CLINICAL CODE, STATES INSUFFICIENT INFORMATION (4580) AS THE PATIENT'S INJURIES AND/OR CAUSE OF DEATH WAS NOT PROVIDED IN THE REPORT. THE DEVICE WAS NOT RETURNED TO VENTEC FOR EVALUATION. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTING USER FACILITY IN ORDER TO OBTAIN THE FIRE MARSHALL REPORT AND ANY OTHER PERTINENT INFORMATION REGARDING THIS EVENT, BUT RESPONSE HAS BEEN RECEIVED. IF FURTHER INFORMATION ABOUT THIS EVENT IS RECEIVED, VENTEC WILL SUBMIT A SUPPLEMENTAL MEDWATCH REPORT. IN THE USER FACILITY MEDWATCH REPORT THAT WAS SENT TO VENTEC, THE REPORTER ADVISED OF THE FOLLOWING: "REPORT RECEIVED FROM COUNTY FIRE MARSHALL ON 4/2/2024 INDICATES THAT HEAT SOURCE: LIGHTER, CIGARETTE, CIGAR; ITEM FIRST IGNITED: PIPE, DUCT, CONDUIT, HOSE; TYPE OF MATERIAL FIRST IGNITED: PLASTIC; CAUSE OF IGNITION: UNINTENTIONAL; FACTORS CONTRIBUTING TO IGNITION: MISUSE OF MATERIAL OR PRODUCT, OTHER; EQUIPMENT INVOLVED IN IGNITION: OXYGEN ADMINISTRATION EQUIPMENT." THE PERFECTO2 V 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 PERFECTO2 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, PERFECTO2 V USER MANUAL] "NO SMOKING" [P. 8, PERFECTO2 V USER MANUAL]. BASED ON THIS INFORMATION, VENTEC HAS DETERMINED THAT IT'S REASONABLE TO CONCLUDE THAT THE CAUSE OF THE REPORTED ISSUE WAS USER ERROR. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE PREVIOUS DEVICE MANUFACTURER, INVACARE, PROVIDED VENTEC WITH A COPY OF MEDWATCH REPORT NUMBER 101545-2024-0006, WHICH STATED THE FOLLOWING: ¿ON 3/22/2024-SPOUSE OF PATIENT CALLED TO REPORT THAT PATIENT HAD EXPIRED IN FIRE IN HER HOME. PER CALL, HE TRIED TO ASSIST THE PATIENT BUT WAS UNABLE TO. REPORT RECEIVED FROM COUNTY FIRE MARSHALL ON 4/2/2024 INDICATES THAT HEAT SOURCE: LIGHTER, CIGARETTE, CIGAR; ITEM FIRST IGNITED: PIPE, DUCT, CONDUIT, HOSE; TYPE OF MATERIAL FIRST IGNITED: PLASTIC; CAUSE OF IGNITION: UNINTENTIONAL; FACTORS CONTRIBUTING TO IGNITION: MISUSE OF MATERIAL OR PRODUCT, OTHER; EQUIPMENT INVOLVED IN IGNITION: OXYGEN ADMINISTRATION EQUIPMENT. THE ENTIRE STRUCTURE AS WELL AS CONTENTS OF HOME DESTROYED.¿ SECTION 3B, GENDER, OF MEDWATCH REPORT NUMBER 101545-2024-0006 INDICATED "CISGENDER WOMAN/GIRL¿. INVACARE HAS PREVIOUSLY ADVISED VENTEC THAT THE UDI INFORMATION FOR THEIR DEVICES IS NOT AVAILABLE; THEREFORE, SECTION D4, UDI, IS "UNKNOWN." SECTION D10, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES, OF THE VENTEC ESUB FORM DOES NOT ALLOW FOR MULTIPLE ENTRIES. THE FOLLOWING CONCOMITANT MEDICAL PRODUCTS AND THERAPY START DATES WERE PROVIDED BY THE REPORTER IN THE MEDWATCH FORM 3500A THAT WAS PROVIDED TO VENTEC. NO END DATES WERE PROVIDED. 1. E-CYLINDER WITH CART: (B)(6) 2023. 2. SUCTION MACHINE: (B)(6) 2023. 3. NEBULIZER COMPRESSOR: (B)(6) 2023. 4. COMMODE 3-N-1: (B)(6) 2023. 5. SHOWER CHAIR: (B)(6) 2023. 6. WHEELCHAIR TRANSPORT 19": (B)(6) 2023. 7. WHEELCHAIR CUSHION 18IN: (B)(6) 2023. 8. WHEELCHAIR FOOT RESTS: (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489616 PERFECTO2V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death