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 07/23/2020

Event Type  Injury  

Manufacturer Narrative

The patient sustained burns to her face and in other areas of her body where the cannula had contact as it burned.The patient received treatment for the burns at the hospital.The degree of the burns, the specific medical treatment received, and the reason for the patient's hospitalization is unknown; hospice would not provide this information, citing hipaa.There was no alleged malfunction/deficiency with the concentrator.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.The dealer advised that the no smoking warning labels were present on the concentrator, and the patient was aware that she should not use the concentrator while smoking.

Event Description

The dealer reported that a hospice facility notified them that a patient caught herself on fire, as she was smoking in bed while using an irc5po2v concentrator.She was admitted to the hospital following the incident.

• 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: 10466571
• MDR Text Key: 204753292
• Report Number: 1031452-2020-00027
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/07/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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