MAUDE Adverse Event Report: INVACARE PERFECTO 2-V; OXYGEN CONCENTRATOR

Model Number IRCP02V

Device Problems Improper or Incorrect Procedure or Method (2017); 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 11/01/2018

Event Type  Death  

Event Description

The pt was smoking with oxygen on and caused a fire.Pt sustained 2nd and 3rd degree burns to 30% of his body on the left side.Pt died on (b)(6) 2018.The pt was found in bed with the mattress on fire, the pt had flames on his clothes and oxygen on.

• Brand Name: PERFECTO 2-V
• Type of Device: OXYGEN CONCENTRATOR
• Manufacturer (Section D): INVACARE; one onvacare way; elyria OH 44036
• MDR Report Key: 8043182
• MDR Text Key: 126297385
• Report Number: 8043182
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: IRCP02V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2018
• Distributor Facility Aware Date: 11/02/2018
• Device Age: 4 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/05/2018
• 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
• Treatment: OXYGEN CONCENTRATOR
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 56