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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC10LXO2
Device Problems Power Switch; Device Alarm System
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

Provider states power switch causing no alarm and compressor is loud.

 
Manufacturer Narrative

Product has been returned and evaluated. The underlying cause documented on the return fields (isp) in oracle is identified as: assembly/component issue / compressor, unable to test.

 
Event Description

Provider states power switch causing no alarm and compressor is loud.

 
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Brand NamePLATINUM 10 CONCEN W/SENS O2 9153642105
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 Key5055756
Report Number1031452-2015-15831
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Followup
Report Date 09/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC10LXO2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/14/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2015
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: 09/04/2015 Patient Sequence Number: 1
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