MAUDE Adverse Event Report:; OXYGEN CONCENTRATOR

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

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 12/17/2018

Event Type  Death  

Event Description

Pt was found in her room by her son on fire from smoking a cigarette with her oxygen on.Pt's oxygen setting was 4l via nasal cannula.Son called 911 and pt was transported to (b)(6) hospital and later transferred to the burn unit and died at 0646 on (b)(6) 2018.On (b)(6) 2018, per staff report, pt was admitted to (b)(6) hospital burn unit for 40% burns to abdomen and chest along with inhalation burns where she later died (b)(6) 2018.Unable to obtain hospital records at this time.Hme was notified of the event and mfr's info was requested at that time.At this time the mfr's info is not known.So this report is just being submitted to fda.

• Brand Name: UNK
• Type of Device: OXYGEN CONCENTRATOR
• MDR Report Key: 8203237
• MDR Text Key: 131639404
• Report Number: 8203237
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2018
• Distributor Facility Aware Date: 12/17/2018
• Event Location: Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 80 YR
• Patient Weight: 50