MAUDE Adverse Event Report: AIRSEP CORP. VISIONAIRE V; 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 Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/10/2015

Event Type  Injury  

Event Description

Patient on oxygen at 4 lpm and lit a cigarette, sustained 2nd degree burn to right cheek, nasal passages and right upper lip.Transported to ed via 911, subsequently admitted for observation to burn unit, discharged home the same day.Prescribed topical ointment to burns.

Manufacturer Narrative

Vitas healthcare reported patient failed to follow instructions lighting a cigarette while using oxygen and no known device failure.

• Brand Name: VISIONAIRE V
• 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: 4709280
• MDR Text Key: 5724225
• Report Number: 1319044-2015-00007
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K872534
• 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

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-101
• Device Catalogue Number: AS098-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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: 64 YR
• Patient Weight: 84