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

Model Number AS098-5

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The device was returned for a standard warranty repair.No adverse event was reported by the customer.A repair inspection identified a scorched circuit board, which is an expected side effect of a faulty eq valve.

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 was evaluated.With the eq valve measuring 0 ohms, findings are consistent with a faulty eq valve coil causing the circuit board to burn out.The device will not turn on.There is no patient risk, other than the device not functioning at all.

• Brand Name: VISIONAIRE
• Type of Device: CONCENTRATOR, OXYGEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 9702345
• MDR Text Key: 188062901
• Report Number: 3004972304-2020-00005
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AS098-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1