MAUDE Adverse Event Report: CAIRE INC. NEWLIFE INTENSITY 10; CONCENTRATOR, OXYGEN, STATIONARY

Model Number AS099-101

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device has been returned for evaluation.If any new information is discovered, a follow-up mdr will be submitted.

Event Description

This report was originally submitted on 11/15/2017, and is being resubmitted on 3/20/2020 as the original submission failed to go through.Unit reported to be having electrical problem and smells like it's burning.No smoke, just smells hot.There were no injuries to patients or the provider.

Manufacturer Narrative

The unit was returned and evaluated.During the course of this test, no abnormal behavior was observed.The unit did not smoke and all of the components appeared to be in good condition.Although the exhaust air did have an odor to it, it did not smell like it was burning.The scent was closer to that of normal plastic, but that is a subjective quality.The odor was only noticeable once the unit had been powered on and the fan was running.The results of this test indicate that the operation of this unit is normal, and it is not believed to be a fire risk.

Event Description

This report was originally submitted on 6/25/2018, and is being resubmitted on 3/20/2020 as the original submission failed to go through.

• Brand Name: NEWLIFE INTENSITY 10
• Type of Device: CONCENTRATOR, OXYGEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 9862600
• MDR Text Key: 188213641
• Report Number: 3004972304-2017-00039
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K960309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AS099-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Date Manufacturer Received: 10/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1