MAUDE Adverse Event Report: AIRSEP CORP. NEWLIFE INTESITY 10; OXYGEN CONCENTRATOR

Model Number AS099-100

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/12/2015

Event Type  Injury  

Event Description

(b)(4) rn received a call from patient's son stating "my mother set herself on fire".He stated that she had lit a cigarette with her oxygen on, resulting in a large burst of flame.Patient has burns on her face, left hand and left foot.Patient was transferred to emergency dept at (b)(6) hosp for evaluation.She was diagnosed with second degree burns and released on the same day.

Manufacturer Narrative

Patient's son reported to (b)(4) that his mother lit a cigarette while on oxygen.(b)(4) reported the patient failed to follow instructions lighting a cigarette while using oxygen and no known device failure.

• Brand Name: NEWLIFE INTESITY 10
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): AIRSEP CORP.; 260 creekside dr.; buffalo NY 14228
• Manufacturer Contact: peter weisenborn ; 260 creekside dr.; buffalo, NY 14228 ; 7166910202
• MDR Report Key: 4709255
• MDR Text Key: 5725382
• Report Number: 1319044-2015-00008
• 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: 04/16/2015

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: 03/19/2015
• Initial Date FDA Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 75