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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problems Fire (1245); Use of Device Problem (1670)
Patient Problems Death (1802); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 11/01/2018
Event Type  Death  
Manufacturer Narrative

There was no alleged malfunction/deficiency with the device. Based on the information provided, 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. Multiple attempts have been made to contact the facility to obtain further information about the event and to request the return of the device. However, the attempts were unsuccessful; no further communication has been received from the facility. Should additional information become available, a supplemental record will be filed.

 
Event Description

A medwatch report was received from a facility alleging that the patient was smoking while using an irc5po2v concentrator, causing a fire. The facility stated that they found the patient in bed with his oxygen on, the mattress was on fire, and there were flames on the patient's clothes. The patient sustained 2nd and 3rd degree burns to 30% of his body on the left side. He was transferred to a hospital icu burn unit, and he subsequently died.

 
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Brand NameINVACARE PERFECTO2 V OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, 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 Key8128668
MDR Text Key129180233
Report Number1031452-2018-00014
Device Sequence Number0
Product Code CAW
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Type of Report Initial
Report Date 11/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2018
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC5PO2V
Device Catalogue NumberIRC5PO2V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2018
Is The Device Single Use? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/04/2018 Patient Sequence Number: 1
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