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 a dialysis center, who reported that the unit "wasn't working properly and when shifting the unit, it would occasionally turn on.After shifting the unit once, fire shot out of the back of the unit where they assume there is a short." there is no report of serious injury.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: 18660592
• MDR Text Key: 334778198
• Report Number: 2515872-2024-00006
• 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 Model Number: 525DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1