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 Insufficient Information (4580)

Event Date 02/05/2021

Event Type  Death  

Manufacturer Narrative

Photographs of the patient's home were provided, showing that it had sustained fire damage.An irc5po2v concentrator was present in the home, along with an oxygen cylinder that appears to have been manufactured by drive medical.The exterior of the irc5po2v concentrator exhibited damage that is consistent with exposure to an external heat source.The dealer recovered the concentrator from the patient's home and has it quarantined.They were unable to perform testing on the device, presumably due to the damage it sustained from the fire.The dealer stated they will not return the unit to invacare.There was no alleged malfunction or defect 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.

Event Description

A report was received from the dealer stating that they were made aware of a house fire that resulted in a patient's death.The dealer advised that an irc5po2v concentrator was in the home at the time of the fire.The dealer provided a fire report for this incident, which stated that the cause of the fire was that the patient was smoking while on oxygen.The patient's exact cause of death is unknown.

• 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: 11597565
• MDR Text Key: 243218794
• Report Number: 1031452-2021-00008
• 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: 03/05/2021

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: 03/05/2021
• Initial Date FDA Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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): Death