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

Model Number AS005-1

Device Problems Mechanical Problem (1384); Environmental Particulates (2930); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

The company is requesting the unit back for evaluation.If an examination can be completed or if any new information is discovered, a followup report will be submitted.

Event Description

The company was informed on january 27, 2017 of an adverse event that occurred on (b)(6) 2016.The patient claims that white dust emitted from the concentrator and that residue was left throughout the patient's house.The patient claims that the dust exacerbated her copd and caused her to be hospitalized.

Event Description

This report was originally submitted on 8-13-2018, and is being resubmitted on 3-06-2020 as the original submission failed to go through.

Manufacturer Narrative

The unit was returned for evaluation.Although the unit was covered in dust, it was not found to be exiting through the cannula port and was instead being discharged internally.Without a laboratory analysis, it is also not possible to determine whether this dust is composed of sieve material or not.The evidence suggests this unit was used in a dirty environment and all of the components appear to be original.The battery that powers the pressure alarm was old and no longer connected to the system at the time of this test.However, it is unclear when this battery was removed.According to the adverse event form, this unit had been in service for nearly nine years.The right sieve bed cylinder was no longer under compression by the spring when it was examined.It is unclear if this was a cause or a result of the issue.Although the weight of sieve in the right bed was out of spec, this may have been the result of collecting dirt and moisture and no conclusion can be made as to whether this contributed to the issue.

• Brand Name: NEWLIFE ELITE
• Type of Device: OXYGEN CONCENTRATOR, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 6362381
• MDR Text Key: 68465963
• Report Number: 3004972304-2017-00005
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS005-1
• Device Catalogue Number: AS005-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Date Manufacturer Received: 01/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization