MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; GENERATOR, OXYGEN, PORTABLE

Model Number 525DS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 01/17/2024

Event Type  Injury  

Event Description

Devilbiss healthcare was notified of an incident by medwatch # (b)(4) from vitas healthcare, which reported that a patient was smoking with oxygen on and sustained 2nd and 3rd degree burns to the face, head, neck and chest, totaling 6% of the body surface.The patient was transferred to a burn unit and ventilated.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 concentrator is located.If unable to leave the room, you must wait 10 minutes after you have turned off the oxygen concentrator before smoking.Oxygen makes it easier for a fire to start and spread.Do not leave the nasal cannula or mask on bed coverings or chair cushions if the oxygen concentrator is turned on but not in use.The oxygen will make the materials flammable.Turn the oxygen concentrator off when not in use to prevent oxygen enrichment.Keep the oxygen concentrator and cannula at least 2 m (6.5 feet) from hot, sparking objects or naked sources of flame.Open flames during oxygen therapy are dangerous and are likely to result in fire or death.Do not allow open flames within 2 m (6.5 feet) of the oxygen concentrator or any oxygen carrying accessories.Drive devilbiss oxygen concentrators are equipped with a fire mitigating outlet fitting that prevents propagation of fire into the unit." devilbiss healthcare will update this report should any additional information become available.

• Brand Name: DEVILBISS
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 18764085
• MDR Text Key: 336049309
• Report Number: 2515872-2024-00010
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 525DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Male