MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2V

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Following the incident, the dealer recovered the concentrator; it was inspected and passed all testing.There was no alleged malfunction or defect with the device.Based on the information provided, the underlying cause of the event is user error; the patient did not adhere to the device labeling and instructions.The irc5po2v user manual states, "do not smoke while using this device.Do not use near open flame or ignition sources.No smoking signs should be prominently displayed.Keep all matches, lighted cigarettes, electronic cigarettes or other sources of ignition out of the room in which this concentrator is located and away from where oxygen is being delivered." in addition, the device itself is prominently labeled regarding the hazard of smoking or exposing the unit to an open flame/ignition source.

Event Description

The dealer reported that the patient lit a cigar while using his irc5po2v oxygen concentrator and it flamed and burned his nose, face, and chest.The patient was admitted to the hospital's burn unit where his wounds were wrapped and treated with burn cream; no skin grafts were required.

• Brand Name: INVACARE PERFECTO2 V OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 10810025
• MDR Text Key: 215318416
• Report Number: 1031452-2020-00041
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2020

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: IRC5PO2V
• Device Catalogue Number: IRC5PO2V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization