MAUDE Adverse Event Report: CAIRE INC. FREESTYLE 3; OXYGEN CONCENTRATOR, PORTABLE

Model Number AS095-2

Device Problems Improper Flow or Infusion (2954); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 11/14/2019

Event Type  Injury  

Event Description

The incident was reported by a primary care professional.A (b)(6) year old woman with home oxygen was assessed for dyspnea.She was assessed the previous day for the same reason by home notice.The patient stated she was not able to breathe.It was reported that the patient had the following symptoms: oxygen saturation: 40%, blood pressure: 80/40, chill hands, sweating, decreased level of consciousness.The patient was sent to the emergency room, received treatment, and recovered from the stated symptoms.The staff identified the patient's portable oxygen device as a possible problem.It had a 75% charged battery.The patient's caregiver stated that the device was set to 2 lpm, but the patient continually changed it to 3 lpm insufficiently.

Manufacturer Narrative

"pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services,subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neitherthis report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caireinc., or caire inc.'s employees, caused or contributed to the reportable event stated herein." the unit was returned to caire for an evaluation on 7/14/2020.The unit was evaluated, and the low fluctuating o2 purity indicates that the device requires repair.There is possible nicotine contamination to the device.

• Brand Name: FREESTYLE 3
• Type of Device: OXYGEN CONCENTRATOR, PORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 9851269
• MDR Text Key: 188211971
• Report Number: 3004972304-2020-00009
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS095-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR