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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 Device Alarm System (1012)
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 states the unit has no breath alarm.
 
Manufacturer Narrative
Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.However, the device issue of no breath alarm was not able to be duplicated, so the original complaint issue was not able to be confirmed.The issue of the unit auto pulsing was confirmed.
 
Event Description
Dealer states the unit has no breath alarm.
 
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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 Key5963078
MDR Text Key55447183
Report Number1031452-2016-03622
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
Type of Report Initial,Followup
Report Date 10/03/2016
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 Manufacturer10/03/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/01/2016
Initial Date FDA Received09/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/17/2016
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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