MAUDE Adverse Event Report: AIRSEP CORP. VISIONAIRE; OXYGEN CONCENTRATOR

Model Number AS098-104

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 04/01/2014

Event Type  Injury  

Event Description

The pt was smoking and using oxygen (visionaire oxygen concentrator).Pt has burns to her skin.

Manufacturer Narrative

Device being returned for eval.A f/u report will be submitted after eval is completed.

• Brand Name: VISIONAIRE
• 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: 4612091
• MDR Text Key: 15841745
• Report Number: 1319044-2015-00005
• 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: Other
• Type of Report: Initial
• Report Date: 03/16/2015

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: AS098-104
• Device Catalogue Number: AS098-104
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• 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: 62 YR