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

Model Number NA:IRC5PO2V

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 07/27/2019

Event Type  Injury  

Manufacturer Narrative

When the issue took place, long tubing was being used to connect the concentrator in the laundry room to the end user in her bedroom.The device has not been evaluated by invacare.The dealer was able to retrieve and test the concentrator, it ran for a day with no issues.The caller stated that the end user does not smoke.He related others living in the home smoke, but not indoors.The driver who picked up the device thought that he smelled cigarette smoke in the home.Should additional information become available, a supplemental record will be filed.

Event Description

The son-in-law reported that the end-user was using the irc5po2v stationary concentrator while in bed when he heard her yelling.He went into the room and saw a flash of red and yellow coming from the end-user¿s face.The caller advised that the nasal cannula was on fire, the two plastic pieces that went into the end-user¿s nose melted together and melted to her face.The daughter was able to put the fire out, which took about forty seconds.They disconnected the cannula from the unit, turned the unit off, unplugged the unit from the wall and called 911.The end-user was transported to the local hospital and then a burn center where she was admitted.She is being treated for extensive burns on the inside and outside of her nose, burns to her mouth, the right and left the side of her face, and swelling of her eye and lips.

• 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 44036 ; 8003336900
• MDR Report Key: 8906642
• MDR Text Key: 154747932
• Report Number: 1031452-2019-00022
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:IRC5PO2V
• Device Catalogue Number: IRC5PO2V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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; Required Intervention