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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 Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 Name
XPO2 PORTABLE CONCENTRATOR 9153648166
Type of Device
GENERATOR, 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
MDR Text Key34914143
Report Number1031452-2015-17290
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 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
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 12/14/2015
Initial Date FDA Received01/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/04/2016
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
Patient Sequence Number1
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