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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS SOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number TPO100B
Device Problems Sticking; Switch, Push Button
Event Type  Malfunction  
Manufacturer Narrative

The product was returned on (b)(4) 2015 for evaluation. The results of the return evaluation were not available for review at the time of this investigation. If new information becomes available at a later date this complaint will be updated &/or a follow up be sent.

 
Event Description

The consumer stated the unit has the stuck button problem.

 
Manufacturer Narrative

The device was evaluated by the returns department which found that the pcb is defective, the valves are defective, and the controls switch/button is broken.

 
Event Description

The consumer stated the unit has the stuck button problem.

 
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Brand NameSOLO2 TRANSPORTABLE OXYGEN CONCENTRATOR 9153650707
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 Key5024378
Report Number1031452-2015-15600
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation PATIENT
Type of Report Followup
Report Date 09/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTPO100B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2015
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: 08/24/2015 Patient Sequence Number: 1
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