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

Model Number AS098-1

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/05/2017

Event Type  Death  

Manufacturer Narrative

The unit has not been returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

Fire occurred in an apartment building.A fatal incident occurred.There were several different items in area where fire occurred including an oxygen concentrator and an electric fan.

Event Description

Unit was visually inspected on-site of the incident.Smoking materials were prevalent throughout the apartment.Initial observations are consistent with the fire originating outside of the oxygen concentrator.

• Brand Name: VISIONAIRE
• Type of Device: CONCENTRATOR, OXYGEN, STATIONARY
• 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 ; 7707217700
• MDR Report Key: 6773590
• MDR Text Key: 82110062
• Report Number: 3004972304-2017-00018
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K872534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-1
• Device Catalogue Number: AS098-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR