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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. NEWLIFE INTESNITY NEWLIFE INTENSITY

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CAIRE INC. NEWLIFE INTESNITY NEWLIFE INTENSITY Back to Search Results
Model Number NEWLIFE INTENSITY
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 03/29/2016
Event Type  Death  
Event Description

The company was informed on (b)(4) 2016 of an alleged incident that occurred on (b)(6) 2016. The alleged incident was described to the company as follows: "two (b)(6) fire fighters arrived at (b)(6) branch, (b)(6) 2016 at 10 am to report a fire in an apartment over the weekend that resulted in the death of a (b)(6) oxygen client. The client was alone at the time of the fire and no other parties were injured in the apt building. As per the fire fighters, the incident is under investigation with no current explanation of cause of fire. As per the fire fighters, the airsep 10 lpm oxygen concentrator was burned badly and the client did not have any facial burns. " the unit is currently quarantined at the (b)(6) fire department. The company is attempting to get the unit back for testing purposes.

 
Manufacturer Narrative

A destructive exam was conducted on thursday (b)(6) 2016 in which x-ray technology was used. The lead fire investigator stated that he felt the fire was outside of the concentrator and that the exam verified that. The other experts all agreed that the concentrator was attacked by the fire which likely was caused by smoking which set the couch on fire.

 
Event Description

The company was informed on april 8, 2016 of an alleged incident that occurred on (b)(6) 2016. The alleged incident was described to the company as follows: "two (b)(4) fire fighters arrived at (b)(6), (b)(6), 2016 at 10 am to report a fire in an apartment over the weekend that resulted in the death of a (b)(4) aire oxygen client. The client was alone at the time of the fire and no other parties were injured in the apt building. As per the fire fighters, the incident is under investigation with no current explanation of cause of fire. As per the fire fighters, the airsep 10 lpm oxygen concentrator was burned badly and the client did not have any facial burns. " the unit is currently quarantined at the (b)(6) fire department. The company is attempting to get the unit back for testing purposes.

 
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Brand NameNEWLIFE INTESNITY
Type of DeviceNEWLIFE INTENSITY
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
Manufacturer (Section G)
CAIRE INC.
500 commerce drive
buffalo NY 14228
Manufacturer Contact
neal maloy
2200 airport industrial drive
suite 500
ball ground, GA 30107
7707217712
MDR Report Key5615072
MDR Text Key43887764
Report Number3004972304-2016-00013
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK960309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberNEWLIFE INTENSITY
Device Catalogue NumberAS099-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/28/2016 Patient Sequence Number: 1
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