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U.S. Department of Health and Human Services

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

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INVACARE FLORIDA PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number NA:IRC5PO2V
Device Problem Adverse Event Without Identified Device or Use Problem
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.

 
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Brand NamePERFECTO2 V WITH SENSOR 9153650799
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 44036
8003336900
MDR Report Key9888180
Report Number1031452-2020-00007
Device Sequence Number1
Product CodeCAW
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 Received03/27/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberNA:IRC5PO2V
Device Catalogue NumberIRC5PO2V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/27/2020 Patient Sequence Number: 1
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