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

Model Number NA:IRC5PO2V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 02/23/2020

Event Type  Death  

Manufacturer Narrative

This report is being filed in an abundance of caution.The dealer stated to the best of their knowledge the concentrator was not the cause of any injury or damage.The concentrator has been recovered by the dealer and is currently in quarantine.The dealer will not return the concentrator at this time.The user manual part #1193322-a-04 page 8 states: "danger! risk of death, injury, or damage from fire textiles, oil or petroleum substances, grease, greasy substances and other combustibles are easily ignited and burn with great intensity in oxygen enriched air and when in contact with oxygen under pressure.To avoid fire, death, injury or damage: do not smoke while using this device.Do not use near open flame or ignition sources.Do not use any lubricants on concentrator unless recommended by invacare.No smoking signs should be prominently displayed.Avoid creation of any spark near oxygen equipment.This includes sparks from static electricity created by any type of friction.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.Keep the oxygen tubing, cord, and concentrator out from under such items as blankets, bed coverings, chair cushions, clothing, and away from heated or hot surfaces including space heaters, stoves, and similar electrical appliances.Should additional information become available, a supplemental record will be filed.

Event Description

Hospice reported to the dealer, that the patient was smoking while using the irc5po2v oxygen concentrator, caught himself on fire and expired.

• 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: 9888180
• MDR Text Key: 185201546
• Report Number: 1031452-2020-00007
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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