MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PLATINUM 10 OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number IRC10LXO2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Death (1802)

Event Date 10/22/2019

Event Type  Death  

Manufacturer Narrative

This event is being reported to the fda in an abundance of caution, due to the alleged death.However, it has not yet been definitively confirmed that the death was a result of the incident, and the severity of the patient's burn injury is unknown.Additional details of the incident have been requested from the dealer, who advised that they are still gathering more information and will respond when they know more.At this time, there has been no allegation of a malfunction/deficiency with the device.Based on the available information, the event was a result of use error; the patient did not adhere to the device labeling and instructions.The platinum series oxygen concentrator owner's manual states, "do not smoke while using this device.Keep all matches, lighted cigarettes or other sources of ignition out of the room in which this product 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.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer sent a communication stating, "we were notified patient sustained burns while smoking on oxygen.We were notified patient expired.".

Manufacturer Narrative

The dealer provided additional information.They advised that they performed testing on the unit after the incident, and no alarms were produced.They also provided photographs of the unit, both external and internal, which show that it did not sustain any damage from the incident.This information supports the previous indications that the event was not the result of a device malfunction but was solely due to use error.The dealer confirmed that the patient was given the concentrator owner's manual, and they were warned not to smoke while using the device.The dealer had no further information regarding any medical treatment the patient may have received following the incident, and the patient's cause of death remains unknown.

Event Description

The dealer sent a communication stating, "we were notified patient sustained burns while smoking on oxygen.We were notified patient expired.".

• Brand Name: INVACARE PLATINUM 10 OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• MDR Report Key: 9370522
• MDR Text Key: 167837488
• Report Number: 1031452-2019-00107
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IRC10LXO2
• Device Catalogue Number: IRC10LXO2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1