MAUDE Adverse Event Report: CAIRE INC. AIRSEP NEWLIFE INTENSITY 10

Model Number AS099-101

Device Problem Device Emits Odor (1425)

Patient Problem No Code Available (3191)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

The unit has been returned for non-destructive testing.Once the testing has been completed a followup report will be submitted.

Event Description

The company was informed on (b)(6) 2016 of an adverse event that occurred on (b)(6) 2016 allegedly involving a newlife intensity.Per an email from a company sales representative, a local cancer center used the 10l newlife intensity unit for the first time and it was emitting a harsh plastic burning type smell.Supposedly the patient complained to the staff that he couldn't breathe and they took him to the hospital where he was treated.

Manufacturer Narrative

The company received the unit for investigation.The company was able to duplicate the customer complaint.Initially, the concentration at 10lpm was 94%.After running for approximately 1.5 hours, the unit stalled and alarmed.The manifold pressure was higher than normal at 37 psi.The compressor current was at 9 amps.The company investigated the sieve beds and took the product caps off.The beds were properly filled, springs were present, and the feed cap baffles were properly installed.Beds appeared to be fine.Beds were reassembled and reinstalled back in the concentrator.The concentrator operated for 374 hours, did not shut down and operated within specification.As a result, the company could not determine what the root cause of the failure was.Based on the symptoms it is possible that debris got into the system causing an intermittent high pressure condition.

Event Description

The company was informed on (b)(6) 2016 of an adverse event that occurred on (b)(6) 2016 allegedly involving a newlife intensity.Per an email from a company sales representative, a local cancer center used the 10l newlife intensity unit for the first time and it was emitting a harsh plastic burning type smell.Supposedly the patient complained to the staff that he couldn't breathe and they took him to the hospital where he was treated.

• Brand Name: AIRSEP NEWLIFE INTENSITY 10
• Type of Device: NEWLIFE INTENSITY 10
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7707217712
• MDR Report Key: 5658064
• MDR Text Key: 45279993
• Report Number: 3004972304-2016-00019
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS099-101
• Device Catalogue Number: AS099-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization