MAUDE Adverse Event Report: INVACARE INVACARE; OXYGEN CONCENTRATOR

Model Number DEFECTO 5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 04/18/2017

Event Type  Injury  

Event Description

Pt was smoking while on oxygen and received second and third degree burns.Dates of use: (b)(6) 2016 - (b)(6) 2017.

• Brand Name: INVACARE
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): INVACARE; philadelphia PA
• MDR Report Key: 6560552
• MDR Text Key: 74947562
• Report Number: MW5069700
• Device Sequence Number: 1
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DEFECTO 5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 88 YR