MAUDE Adverse Event Report: AIRSEP CORP. NEWLIFE INTENSITY 10; 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 patient 3 cigarettes before he went to the back room of the house.Patient had oxygen on and was smoking.Conflicting stories have been given as to whether the patient used a lighter to light the cigarette or if the patient fell asleep with the cigarette, this resulted in a fire which burned the patient, the sofa, and the floor.Husband and grandson attempted to extinguish the fire.The fire department came and patient was taken to (b)(6) medical center burn unit.Patient suffered 3rd degree burns over 55% of her body.She died the next morning.

Manufacturer Narrative

No device failure.Instructions not to smoke while using oxygen no followed.

• Brand Name: NEWLIFE INTENSITY 10
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): AIRSEP CORP.; 401 creekside dr.; buffalo NY 14228
• Manufacturer Contact: peter weisenborn ; 401 creekside dr.; buffalo, NY 14228 ; 7166910202
• MDR Report Key: 4020055
• MDR Text Key: 16853018
• Report Number: 1319044-2014-00014
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2014

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: Lay User/Patient
• Device Model Number: AS099-100
• Device Catalogue Number: AS099-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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: 62 YR
• Patient Weight: 34