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

Model Number AS098-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumonia (2011)

Event Date 05/16/2018

Event Type  Injury  

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." the unit has been returned for evaluation.If any new information is discovered, a follow-up report will be submitted.

Event Description

Patient, (b)(6), contracted pneumonia.The oxygen concentrator device is suspected as the cause of the illness.

Event Description

This report was originally submitted on 10/17/2018, and is being resubmitted on 4/17/2020 as the original submission failed to go through.Patient, 13 years old, contracted pneumonia.The oxygen concentrator device is suspected as the cause of the illness.

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.The device functioned as intended and there were no issues found.It was received in a condition you could expect from a unit in service with a slight dusting of the internal components.

• Brand Name: VISIONAIRE 5
• Type of Device: OXYGEN CONCENTRATOR, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 7607108
• MDR Text Key: 111265788
• Report Number: 3004972304-2018-00022
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-5
• Device Lot Number: BUB0116430747
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR