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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS XPO2 PORTABLE CONCENTRATOR 9153648166 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS XPO2 PORTABLE CONCENTRATOR 9153648166 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number XPO100
Device Problems Display; Break
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

 
Event Description

Dealer is stating that the display is broken.

 
Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation. The result of the evaluation was that the pcb power inlet is broken, causing no display, which confirmed the original complaint issue.

 
Event Description

Dealer is stating that the display is broken.

 
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Brand NameXPO2 PORTABLE CONCENTRATOR 9153648166
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
kevin guyton
one invacare way
elyria , OH 44035
8003336900
MDR Report Key5339933
Report Number1031452-2015-17290
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberXPO100
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/23/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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