MAUDE Adverse Event Report: INVACARE FLORIDA 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597; GENERATOR, OXYGEN, PORTABLE

Model Number NA:IRC5LXO2

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Initial conclusions allege that the event was caused by improper use of the irc5lxo2 concentrator; operator error.Smoking while the concentrator was in use.The user manual pn 1143482-h-00 states, "do not smoke while using this device".In conclusion, it appears that the underlying cause of the event was that the end user failed to adhere to the warnings in the user manual.Should additional information become available, a supplemental record will be filed.

Event Description

The complaint alleges that the end user was smoking while using the concentrator and caught himself on fire and ended up passing away.The dealer confirmed that there is smoke damage to the unit.

Manufacturer Narrative

The irc5lx02 was returned for an expanded evaluation.  there was no evidence of fire or any plastic deformation throughout the interior or exterior of the concentrator.  the concentrator functioned within specification.  based on results of the evaluation it was determined the event was not caused by a malfunction of the device.

Event Description

The complaint alleges that the end user was smoking while using the concentrator and caught himself on fire and ended up passing away.The dealer confirmed that there is smoke damage to the unit.The provider called on (b)(6) 2017 and states the unit is also infested with cockroaches.Provider was asked to use roach bomb and leave it for 24-48 hours so they die and then ship it back.

• Brand Name: 5LTR PLAT CONC W/SESO2 AND HFIIC 9153629597
• 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 44036 ; 8003336900
• MDR Report Key: 6864601
• MDR Text Key: 86115559
• Report Number: 1031452-2017-00054
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:IRC5LXO2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• 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