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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 B
Device Problems Function Indicator; Concentrator; No Audible Alarm; Sticking; Switch, Push Button
Event Type  Malfunction  
Manufacturer Narrative

Product has not been returned for evaluation as of the date of this investigation. Rma was issued. If new information becomes available at a later date this complaint will be updated and/or a follow up be sent.

 
Event Description

Per provider, concentrator is stuck at 5 liters and the minus button to change the liters is not working. Unit is not alarming and there are no indicator lights on the unit.

 
Manufacturer Narrative

The device was evaluated by the returns department which found that the controls switch/button is broken, the sieve bed is saturated, and the sieve bed's cap/o-ring/gasket is leaking.

 
Event Description

Per provider, concentrator is stuck at 5 liters and the minus button to change the liters is not working. Unit is not alarming and there are no indicator lights on the unit.

 
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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 Key5045549
Report Number1031452-2015-15768
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Followup
Report Date 08/31/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberXPO100 B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2015
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 TREATMENT DATA
Date Received: 09/01/2015 Patient Sequence Number: 1
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