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

Model Number AS098-1

Device Problem Use of Device Problem (1670)

Patient Problems Hypoxia (1918); Respiratory Distress (2045); Partial thickness (Second Degree) Burn (2694)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Patient was smoking while using oxygen concentrator and inhaler.Flash fire occurred and patient sustained burns on his face.Patient was taken to the hospital where he was talking when he arrived but was later intubated and transferred to a hospital with a burn unit.Patient treated for 2nd degree burn over bridge of nose, both cheeks and upper lip.Patient also treated for smoke inhalation and had singed nasal hairs and carbonaceous sputum and carbon in the nares.Chest reported to be clear to auscultation with breath sounds equal bilaterally.Patient was extubated on (b)(6) 2015 and reported to be comfortable.Patient was discharged to home on hospice on (b)(6) 2015.

• 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: 4660188
• MDR Text Key: 5729817
• Report Number: 1319044-2015-00006
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K8782534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-1
• Device Catalogue Number: AS098-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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: 69 YR
• Patient Weight: 54