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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 Type  Death  
Manufacturer Narrative

This record is being filed in an abundance of caution. At the time of this filing, no malfunctions or deficiencies have been alleged. The dealer said they have the unit in quarantine, and have no plans to return the unit. On page 9 of the user manual part #1193322-b, it 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. Smoking during oxygen therapy is dangerous and is likely to result in burns or death. To avoid fire, death, injury or damage: 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 open flames, matches, lighted cigarettes, electronic cigarettes or other sources of ignition at least 10 ft (3 m) away from this concentrator or any oxygen carrying accessories such as cannulas or tanks. Should additional information become available, a supplemental record will be filed.

 
Event Description

Invacare received a communication from the dealer that stated, they were notified that a hospice patient was smoking while using an oxygen concentrator and was burned. The patient was airlifted to the hospital and passed away.

 
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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 44035
8003336900
MDR Report Key9779877
Report Number1031452-2020-00005
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberNA:IRC5PO2V
Device Catalogue NumberIRC5PO2V
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2015
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: 03/03/2020 Patient Sequence Number: 1
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