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

Model Number AS098-1

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

The unit is being returned for evaluation.If any new information is discovered, a follow-up report will be submitted.

Event Description

This report was originally submitted on 04/25/2019, and is being resubmitted on 5/14/2020 as the original report failed to go through.Per customer, the dial is broken that controls liter flow of oxygen.Sometimes it just turns endlessly without registering a literflow, like 2 liters.Sometimes the dial shows 5 liters but no oxygen flow.So, inconsistent or no readings.We had a resident on4 liters and he was turning blue, getting more short of breath, and his oxygen levels dropping dramatically.

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, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein." device was returned for evaluation.The failure described by the adverse event form could not be replicated while testing the visionaire oxygen concentrator in question.Visual inspections and functional tests showed that the concentrator test unit is undamaged and it operates within its functional specifications, both in its output flow and in its oxygen purity.Furthermore, the inconsistent flow described by the costumer could not be confirmed.The measured fluctuations at 4 lpm, the unit's output flow at the time of the incident, are minimal and would not be detectable by the user without a high precision flow meter.

Event Description

This report was originally submitted on 07/02/2019, and is being resubmitted on 5/21/2020 as the original report failed to go through.Per customer, the dial is broken that controls liter flow of oxygen.Sometimes it just turns endlessly without registering a literflow, like 2 liters.Sometimes the dial shows 5 liters but no oxygen flow.So, inconsistent or no readings.We had a resident on 4 liters and he was turning blue, getting more short of breath, and his oxygen levels dropping dramatically.

• Brand Name: VISIONAIRE 5
• Type of Device: OXYGEN CONCENTRATOR, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground, ga
• MDR Report Key: 10057546
• MDR Text Key: 190986348
• Report Number: 3004972304-2019-00026
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K872534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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: AS098-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other