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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number NA:IRC10LXO2
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 08/22/2019
Event Type  Death  
Manufacturer Narrative

An invacare expert attended a two day inspection. His verbal opinion was the invacare concentrator was not the cause of the fire and explosion based in part on the location of the concentrator relative to the origin of the fire. The fire started in the patient¿s room on the other side of the home. The concentrator was kept in another room, tubing carried the o2 from the concentrator to the patient. Should additional information become available, a supplemental record will be filed.

 
Event Description

Invacare was notified of a house fire resulting in a patient¿s death. An invacare irc10lx02 concentrator was in the patient¿s home.

 
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Brand NamePLATINUM 10 CONCEN W/SENS O2 9153642105
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 Key9286889
MDR Text Key165306839
Report Number1031452-2019-00030
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberNA:IRC10LXO2
Device Catalogue NumberIRC10LXO2
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2017
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: 11/06/2019 Patient Sequence Number: 1
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