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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRSEP CORPORATION AIRSEP NEWLIFE ELITE STATIONARY OXYGEN CONCENTRATOR

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AIRSEP CORPORATION AIRSEP NEWLIFE ELITE STATIONARY OXYGEN CONCENTRATOR Back to Search Results
Model Number AS005-4
Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/01/2015
Event Type  Death  
Manufacturer Narrative

The company is attempting to get the unit returned for investigation. A follow-up report will be submitted upon gaining further information.

 
Event Description

The company was notified on (b)(6) 2015 of a house fire that occurred on (b)(6) 2015. An airsep newlife oxygen concentrator was found in the general area of the fire. One of the occupants of the house died in the fire.

 
Manufacturer Narrative

An investigation of the scene and unit occurred with a company representative present. The device underwent an x-ray inspection. The fire was determined to be outside of the unit; however, the fan blades inside the unit were melted and the circuit board showed heat damage from the fire. They located some pieces of the cannula that were burned. The x-ray showed a zipper under the melted unit, suggesting that an item of clothing was draped on or near the unit, and that the unit was on the "off" position at the time of the fire. The electrical cord was also burned. The conclusion of this investigation was that there was nothing wrong with the unit and that it did not contribute to the fire.

 
Event Description

The company was notified on october 30, 2015 of a house fire that occurred on (b)(6) 2015. An airsep newlife oxygen concentrator was found in the general area of the fire. One of the occupants of the house died in the fire.

 
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Brand NameAIRSEP NEWLIFE ELITE
Type of DeviceSTATIONARY OXYGEN CONCENTRATOR
Manufacturer (Section D)
AIRSEP CORPORATION
260 creekside drive
buffalo NY 14228
Manufacturer (Section G)
AIRSEP CORPORATION
260 creekside drive
buffalo NY 14228
Manufacturer Contact
neal maloy
260 creekside drive
buffalo, NY 14228
7707217712
MDR Report Key5261066
MDR Text Key32523973
Report Number1319044-2015-00019
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK872534
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 08/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberAS005-4
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 Received10/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 11/30/2015 Patient Sequence Number: 1
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