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

Model Number 525DS

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the end user, who reported that the tubing caught on fire while on the floor.The end user stated the concentrator was "running hotter than normal, has been humming with a yellow light" for two months.However, the end user stated that the machine itself did not catch on fire.All signs of fire were at the distal end of the cannula, and there were no signs of concentrator involvement.The end user stated that there were no open flames or smoking around the unit, so the fire's ignition source is unclear at this time.There is no report of any injury.The user manual for the oxygen concentrator states for yellow light with alarm to "contact your oxygen equipment provider for assistance and to arrange for servicing of the unit".Devilbiss healthcare is in the process of facilitating the return of the product for inspection and 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): DRIVE DEVILBISSHEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 18659698
• MDR Text Key: 334766625
• Report Number: 2515872-2024-00004
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/09/2024
• 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