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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2
Device Problems Power Switch; Device Inoperable; Sparking
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available for the patient, a supplemental record will be filed.

 
Event Description

Dealer states unit will not run at all, and stated it sparked from the power switch.

 
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 pilot valve was defective causing the unit not to run, which confirmed the original complaint issue. However, the complaint of sparking from the power switch was not verified.

 
Event Description

Dealer states unit will not run at all, and stated it sparked from the power switch.

 
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Brand NamePERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963
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 Key5225375
Report Number1031452-2015-16754
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Repair
Type of Report Followup
Report Date 11/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC5PO2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/30/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2015
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

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