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

Model Number AS098-101

Device Problem Noise, Audible (3273)

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

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

Patient claimed that the unit was loud.Unit brought to shop.Once opened up the customer saw that the wires were melted through and had made contact with the compressor.The customer stated that the unit produced o2 @ 95%.The only issue was the noise and vibration coming from the unit.Ran with different compressor and the unit ran normal and produced 95% o2.The problematic compressor has been placed back into unit prior to shipping.

Manufacturer Narrative

Device was returned for evaluation.The user complaint regarding loud sounds emanating from the unit and the damage found on the compressor by the costumer can be explained by the missing mounting spring on the compressor base.An unstable compressor could vibrate against the concentrator's casing, causing loud noises, and it could also vibrate against the compressor leads, causing the abrasive damage to the lead wires.It is unclear how the mounting spring became loose and how it lodged itself in the compressor enclosure padding.

• Brand Name: VISIONAIRE
• Type of Device: OXYGEN CONCENTRATOR, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 7052892
• MDR Text Key: 93301523
• Report Number: 3004972304-2017-00042
• 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: 07/20/2018

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: Lay User/Patient
• Device Model Number: AS098-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1