MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; OXYGEN CONCENTRATOR

Model Number 525DS

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

During a retrospective complaint review, devilbiss healthcare examined a complaint received from a distributor on october 9, 2020 involving a devilbiss oxygen concentrator on which the [?]"the external plastic of the front cabinet demonstrated evidence of thermal distortion and flooring having scorch markings." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Devilbiss evaluated the unit and determined that the oxygen concentrator showed evidence of modest thermal damage on a small section of the external front cabinet, near where the end of the cannula and tubing attaches to the concentrator, and the fire was extinguished at the location of the concentrator firebreak, a metal component intended to prevent the propagation of an external fire into the cabinetry of the device.There was no evidence of fire or thermal damage inside the cabinet and unit.No defect was identified, and the failsafe firebreak performed as intended to prevent further propagation of the fire into the device.The root cause of the fire and thermal damage was determined to be an external heat source while using the oxygen via nasal cannula.Smoking or going near an open flame while using oxygen is in direct contravention of the warnings placed both on the device itself and noted repeatedly in the warnings and cautions contained in the device's instructions for use.

• Brand Name: DEVILBISS
• Type of Device: OXYGEN CONCENTRATOR
• 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: jillian forster ; 99 seaview blvd; port washington, NY 11050 ; 5169984600
• MDR Report Key: 14790426
• MDR Text Key: 303293368
• Report Number: 2515872-2022-00016
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: 885304000846
• 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: Distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• 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