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

Model Number AS098-5

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned for investigation.Results will be submitted via a follow-up mdr once the report is approved.

Event Description

Customer provided sn with fault description "noisy," provided pictures showing charred parts on unit.On (b)(6) 2019 - no incident, unit was sent in to customer for inspection and was found to be noisy - charred parts were found upon further inspection of unit.Unit was handed to patient with 3 working hours and was in use for about 12 months.

Manufacturer Narrative

The unit was returned for investigation.The loud noise complaint that was originally reported by the customer can be duplicated, due to the air leakage from the damaged pressure port tubing.Heat damage to the pressure port tube and the capacitor was found, but functional testing could not determine the root cause.The heat damage on the tube and capacitor appeared to be superficial, and once installed properly on the unit, the components allowed the concentrator to function normally.Additionally, the reported damage was concentrated to the two components, no other wires or tubing exhibited heat or burn damage.

• 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: 9383368
• MDR Text Key: 188211053
• Report Number: 3004972304-2019-00054
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AS098-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1