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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 Display; Break
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 &/or a follow up be sent.

 
Event Description

Dealer states the unit has a broken display.

 
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 reported issued of a broken display could not be duplicated, so the complaint was not confirmed. However, malfunctions were identified: the manifold was leaking and the sieve beds were saturated causing low o2.

 
Event Description

Dealer states the unit has a broken display.

 
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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 Key5347765
Report Number1031452-2016-00018
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Followup
Report Date 02/03/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/06/2016
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 Manufacturer02/03/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2016
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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