MAUDE Adverse Event Report: CAIRE INC. FREESTYLE COMFORT; OXYGEN, CONCENTRATOR, PORTABLE

Model Number AS200-201

Device Problem Device Emits Odor (1425)

Patient Problems Fainting (1847); Loss of consciousness (2418)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

The device has been returned for evaluation.If any new information is discovered, a follow up mdr will be submitted.

Event Description

According to the provider/distributor, the unit doesn't seem to be having any issues.However, the end-user said that he started smelling a bad burning electrical type smell from the unit.The patient was away from home, so he tried to drive back home.He got light-headed and had to pull off of the road.He was going to call 911, but he passed out before he could.He woke up shortly after, and he felt a little better and drove home.The patient didn't go to the hospital or to the doctor, but he was scared to run the unit again.Provider couldn't smell anything when assessing the unit, but the end-user said it was on for hours before that started.

Manufacturer Narrative

Unit was returned for evaluation.During testing of the unit, the unit did not show any form of malfunction.The unit was able to work on battery and ac power.There was no sign of damage on the unit externally or internally to the casing or parts.The unit was able to hold purity within specifications of 87-95.5%.There were no popping or other abnormal sounds while the unit was under test.The unit finally did not produce any smoke or smell under test.

• Brand Name: FREESTYLE COMFORT
• Type of Device: OXYGEN, CONCENTRATOR, PORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 8242164
• MDR Text Key: 132904806
• Report Number: 3004972304-2018-00060
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K020324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS200-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other