MAUDE Adverse Event Report: CAIRE INC. COMPANION 5; CONCENTRATOR, OXYGEN, STATIONARY

Model Number 15067013

Device Problems Material Discolored (1170); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

(b)(6) went to the patient's house because patient said the unit was alarming.When he went there he traded the unit out and brought it back to the company.He just recently noticed the warping / discoloring on the back panel of the unit.Says it looks melted, that it looks like there might have been a fire inside the unit.Says the unit runs fine and has a good o2 concentration.Just worried about the warped / discolored back panel.Thinking it got too hot inside the unit.There were no injuries to the end user.

Manufacturer Narrative

The unit was returned for evaluation.The alarms and overheating described by the adverse event form could not be replicated while testing the companion 5 oxygen concentrator in question.Functional tests showed that the concentrator test unit operates within its functional specifications, both in its output flow and in its oxygen purity.Additionally, the test unit exhibits no abnormal behaviors during extended periods of use.Visual inspections confirmed the warping and discoloration of the test unit's back case, but they also revealed that the damage was primarily external.All internal assemblies were found intact.Because normal operation of the unit cannot incur temperatures high enough to soften the plastic case, the warping and discoloration was likely caused by an unknown exterior heat source.

• Brand Name: COMPANION 5
• Type of Device: CONCENTRATOR, OXYGEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 7180442
• MDR Text Key: 97775610
• Report Number: 3004972304-2017-00052
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K121167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15067013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1