MAUDE Adverse Event Report: INVACARE FLORIDA PLATINUM OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	IRC10LXO2
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: the device was not returned to ventec for evaluation.A label on the oxygen concentrator device itself states, "danger - risk of fire - no smoking, open flame or igniition 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 and burn with great intensity in oxygen enriched air." furthermore, the invacare platinum 10l oxygen concentrator user manual provides the following warning [p.10], "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 flame 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 (3 m) away from this concentrator or any oxygen carrying accessories such as cannulas or tanks." ventec reviewed the information provided in the user facility medwatch.Ventec's investigation determined that the cause of the reported issue was user error, due to the patient's visitor introducing an open flame in very close proximity to the device which was actively delivering oxygen to the patient.These actions resulted in the observed fire and burns/injury to the patient.H3 other text : not returned to manufacturer.
Event or Problem Description
Information regarding the following patient event was provided to ventec via the device's previous device manufacturer, invacare.Medwatch user facility report number 451536-2023-0001 stated the following: at 2035 a nurse, while walking down the hall, noted an orange flickering light in the patient's room.The nurse entered the patient's room and noted fire around the patient's face, which the patient's visitor [redacted] was attempting to extinguish.Simultaneously, a visitor of another patient was reporting at the nurse's station that he saw the flickering of a lighter from the hallway.The nurse immediately turned off the oxygen while pulling the nasal cannula away from the patient's face.Other staff members entered to assist.The fire was quickly extinguished.The nurse notified the physician on call and obtained orders for to provide treatment to multiple areas of redness, blistering and ashy areas on the patient's right shoulder, face, nose, ear and temporal hair line extending to behind her right ear.The visitor, [redacted], apologized profusely and reported, "i was burning off the hair on her chin with a cigarette lighter; this is something we have done for each other for a long time." the reporter advised in the medwatch that the patient was on the oxygen concentrator (receiving oxygen), various medications (not provided) and receiving assistance with activities of daily living (adls).No further details were provided.The previous device manufacturer was unable to provide the device's udi information.As a result, section d4, udi, is "unknown".
Additional Manufacturer Narrative
**udi related data quality updates only** corrected information for supplemental medwatch report 001 ¿ section d4, udi #, of the initial medwatch report stated: unknown.Section d4, udi #, of the initial medwatch report should have stated: (b)(4).
Event or Problem Description
Information regarding the following patient event was provided to ventec via the device's previous device manufacturer, invacare: "at 20:35 a nurse, while walking down the hall, noted an orange flickering light in the patient's room.The nurse entered the patient's room and noted fire around the patient's face, which the patient's visitor [redacted] was attempting to extinguish.Simultaneously, a visitor of another patient was reporting at the nurse's station that he saw the flickering of a lighter from the hallway.The nurse immediately turned off the oxygen while pulling the nasal cannula away from the patient's face.Other staff members entered to assist.The fire was quickly extinguished.The nurse notified the physician on call and obtained orders for to provide treatment to multiple areas of redness, blistering and ashy areas on the patient's right shoulder, face, nose, ear and temporal hair line extending to behind her right ear.The visitor, [redacted], apologized profusely and reported, "i was burning off the hair on her chin with a cigarette lighter; this is something we have done for each other for a long time." " the reporter advised that the patient was on the oxygen concentrator (receiving oxygen), various medications (not provided) and receiving assistance with activities of daily living (adls).No further details were provided.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 002 ¿ section b5, describe event or problem, of the initial medwatch report stated: information regarding the following patient event was provided to ventec via the device's previous device manufacturer, invacare.Medwatch user facility report number (b)(4) stated the following: "at 2035 a nurse, while walking down the hall, noted an orange flickering light in the patient's room.The nurse entered the patient's room and noted fire around the patient's face, which the patient's visitor [redacted] was attempting to extinguish.Simultaneously, a visitor of another patient was reporting at the nurse's station that he saw the flickering of a lighter from the hallway.The nurse immediately turned off the oxygen while pulling the nasal cannula away from the patient's face.Other staff members entered to assist.The fire was quickly extinguished.The nurse notified the physician on call and obtained orders for to provide treatment to multiple areas of redness, blistering and ashy areas on the patient's right shoulder, face, nose, ear and temporal hair line extending to behind her right ear.The visitor, [redacted], apologized profusely and reported, "i was burning off the hair on her chin with a cigarette lighter; this is something we have done for each other for a long time." " the reporter advised in the medwatch that the patient was on the oxygen concentrator (receiving oxygen), various medications (not provided) and receiving assistance with activities of daily living (adls).No further details were provided.The previous device manufacturer was unable to provide the device's udi information.As a result, section d4, udi, is "unknown".Section b5, describe event or problem, of the initial medwatch report should have stated: information regarding the following patient event was provided to ventec via the device's previous device manufacturer, invacare: "at 2035 a nurse, while walking down the hall, noted an orange flickering light in the patient's room.The nurse entered the patient's room and noted fire around the patient's face, which the patient's visitor [redacted] was attempting to extinguish.Simultaneously, a visitor of another patient was reporting at the nurse's station that he saw the flickering of a lighter from the hallway.The nurse immediately turned off the oxygen while pulling the nasal cannula away from the patient's face.Other staff members entered to assist.The fire was quickly extinguished.The nurse notified the physician on call and obtained orders for to provide treatment to multiple areas of redness, blistering and ashy areas on the patient's right shoulder, face, nose, ear and temporal hair line extending to behind her right ear.The visitor, [redacted], apologized profusely and reported, "i was burning off the hair on her chin with a cigarette lighter; this is something we have done for each other for a long time." " the reporter advised that the patient was on the oxygen concentrator (receiving oxygen), various medications (not provided) and receiving assistance with activities of daily living (adls).No further details were provided.

• Brand Name: PLATINUM OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 18385512
• Report Number: 3013095415-2023-00854
• Device Sequence Number: 2767507
• Product Code: CAW
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K020386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: IRC10LXO2
• Device Catalogue Number: IRC10LXO2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 07/18/2024; 08/20/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 07/31/2024; 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White