MAUDE Adverse Event Report: AIRSEP VISION AIRE; OXYGEN CONCENTRATOR

Model Number AS098-101

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Death (1802)

Event Date 12/24/2016

Event Type  Death  

Event Description

(b)(6) was notified by the massage therapist, (b)(6).He said that he saw a report on the news that a man died in a house fire.The massage therapist recognized the house and address.He looked in his records and confirmed it was a patient of (b)(6).He then called (b)(6), on-call rn who then called the patient daughter, (b)(6) to confirm the information and the daughter said that her dad was deceased.According to the fire captain, (b)(6) who is in charge of the fire investigation unit, stated that the circumstantial evidence suggest that the patient was smoking on bed and this was the cause of the fire.He interviewed the family who stated the patient smoked and was a chain smoker.News report also reports that an oxygen tank used by the victim exploded.No other family members injured in the fire.(b)(6) coroner notified on (b)(6) 2016 to obtain time of death.He said the fire occurred on (b)(6) 2016 at 12:35pm and the patient was pronounced at 14:45 pm by the (b)(6) investigation, (b)(6).

• Brand Name: VISION AIRE
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): AIRSEP ; buffalo NY
• MDR Report Key: 6230215
• MDR Text Key: 64083844
• Report Number: 6230215
• Device Sequence Number: 1
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/24/2016,12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-101
• 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: 12/24/2016
• Distributor Facility Aware Date: 12/24/2016
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 12/30/2016
• 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
• Treatment: M6 CARRYING BAG; OXYGEN CONSERVER; OXYGEN CYLINDER - M6; OXYGEN STANDARD REGULATOR; TANK RACK
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 82