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

Model Number	525KS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/15/2021
Type of Reportable Event	Death
Event or Problem Description
Devilbiss healthcare was notified of an incident by the french regulatory agency in which the end user smoked cigarettes while using an oxygen concentrator.Reportedly, the incident was the third time this end user smoked while using the device, and had previously signed a "smoker patient release," because it was noted by the provider that he was still smoking in the presence of his oxygen therapy treatment.The end user was burned and was taken to the hospital where the end user expired.There was no report of a device malfunction.The device contains several warnings, in french, 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." the manufacturer concludes, based on the information provided, that the oxygen concentrator did not malfunction, and the use error of smoking during use caused the adverse event.Devilbiss healthcare will file an update if additional information becomes available.
Additional Manufacturer Narrative
Udi related data quality updates only.The previous submitted report had lacking or incorrect information in sections d1 brand name, d4 udi and "catalogue" number, and the serial number of the device was incorrect.Sections d1 and d4 have been updated with the new "information".The serial number is unknown thus cannot be updated.In addition, the manufacturing date is derived from the serial number and thus is blank as well.

• Brand Name: DEVILBISS
• Common Device Name: 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
• MDR Report Key: 18336398
• Report Number: 2515872-2023-00096
• Device Sequence Number: 8407057
• Product Code: CAW
• UDI-Device Identifier: 00885304000976
• UDI-Public: (01)00885304000976(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 525KS
• Device Catalogue Number: 525KS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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: Death
• Patient Sex: Unknown