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

Model Number AS098-1U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/28/2018

Event Type  Injury  

Manufacturer Narrative

The unit has not been returned for evaluation.Because smoking was reported as the cause, the unit will not be evaluated as there is no reason to suspect a device malfunction.If any new information is discovered, a followup report will be submitted.

Event Description

Patient, non-smoker, decided to smoke a cigarette left in house by a friend.Patient forgot she was wearing her oxygen, and it exploded in her face causing burns to her nose, lips, and cheeks.Singed eyelashes and hair on the left side of her face.

• 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
• MDR Report Key: 7304595
• MDR Text Key: 101234157
• Report Number: 3004972304-2018-00003
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-1U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 117