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

Model Number NA:IRC5PO2V

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

This incident is being reported due to the allegation the patient was admitted to the hospital with burns to their face due to lighting a cigarette while using the concentrator.The severity of the injury and specific treatment received is unknown.There was no alleged malfunction or defect.The patient's son said the concentrator was working fine at the time of the incident.There was no alleged 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 irc5po2v user manual states, "do not smoke while using this device.Do not use near open flame or ignition sources.No smoking signs should be prominently displayed.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." 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

Medwatch report (b)(4) was received from vitas healthcare stating: the patients son reported to vitas that the patient lit a cigarette while using his concentrator.

• 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: 8974777
• MDR Text Key: 156907223
• Report Number: 1031452-2019-00025
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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): Hospitalization; Required Intervention
• Patient Weight: 66