MAUDE Adverse Event Report: AIR SEP AIR SEP; OXYGEN CONCENTRATOR

Model Number AS099-100

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

Patient Problems Death (1802); Full thickness (Third Degree) Burn (2696)

Event Date 06/30/2014

Event Type  Death  

Event Description

After multiple discussions regarding oxygen safety the patient's spouse gave the pt 3 cigarettes before he went to the back room of the house.Pt had o2 on and was smoking.Conflicting stories have been given as to whether the pt used a lighter to light the cigarette or if the pt fell asleep with the cigarette.This resulted in a fire which burned the pt, the sofa and the floor.Husband and grandson attempted to extinguish the fire.The fire department came and pt was taken to (b)(6) medical center burn unit.Pt suffered third degree burns over 55% of her body.She died the next morning.

• Brand Name: AIR SEP
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): AIR SEP; amherst NY 14228
• MDR Report Key: 4021108
• MDR Text Key: 4876658
• Report Number: 4021108
• 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: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AS099-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2014
• Distributor Facility Aware Date: 06/30/2014
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 07/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRESSURE RELIEF MATTRESS; PORTABLE OXYGEN M6 WITH REGULATOR AND CASE PLUS; BIPAP MACHINE; OXYGEN CONCENTRATOR WITH BACKUP; OXYGEN CONSERVING DEVICE; QUAD CANE; FOLDING WALKER WITH WHEELS; 5 ADDITIONAL M6 TANKS; PEDIATRIC WHEELCHAIR; NEBULIZER COMPRESSOR; PORTABLE OXYGEN E WITH REGULATOR AND CART PLUS 5; PATIENT BED ALARM; OVER BED TABLE; ELECTRIC HOSPITAL BED; ADDITIONAL E TANKS
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 34