MAUDE Adverse Event Report: INVACARE FLORIDA PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE

Model Number NA:IRC5PO2V

Device Problem Use of Device Problem (1670)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

The concentrator was not returned for evaluation, so the complaint could not be verified.The end user's healthcare provider would not release the unit for return.Photographs of the unit were requested but have not been provided at this time.The underlying cause of the fire and subsequent injuries was due to the end user smoking while using the concentrator.There was no malfunction of the device.The perfecto2 series oxygen concentrators user 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.No smoking signs should be prominently displayed.Textiles and other materials that normally would not burn are easily ignited and burn with great intensity in oxygen enriched air.Failure to observe this warning can result in severe fire, property damage and cause physical injury or death." the dealer stated that at the time of the incident the "no smoking" warning labels were intact, and the end user had been warned multiple times not to smoke while using the concentrator.Should additional information become available, a supplemental record will be filed.

Event Description

The end user lit a pipe while wearing a nasal cannula with oxygen flowing at 2l nc via an oxygen concentrator.He immediately realized his mistake when he felt and saw the flames from the fire and grabbed the cannula and threw it to the floor.No one was present in the home at the time of the incident.The end user was taken to the hospital er and was treated for 1st and 2nd degree burns to both temples, face, cheeks, and around his nose.He was then transferred to the inpatient unit.

• Brand Name: PERFECTO2 V WITH SENSOR 9153650799
• 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: 6296498
• MDR Text Key: 66362327
• Report Number: 1031452-2017-00001
• 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: health professional
• Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:IRC5PO2V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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
• Patient Age: 70 YR
• Patient Weight: 103