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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problems Power Switch; Device Alarm System
Event Type  Malfunction  
Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

 
Event Description

Provider states 4 way and pilot valve causing 2 green, 1 red light, power switch no alarms.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: 4-way valve contaminated. Complaint was confirmed. The underlying cause could not be determined after reviewing the documentation in this investigation.

 
Event Description

Product was returned for evaluation. The return fields in oracle state: 4-way valve contaminated. Provider states 4 way and pilot valve causing 2 green, 1 red light, power switch no alarms.

 
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Brand NamePERFECTO2 V WITH SENSOR 9153650799
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 Key5069027
Report Number1031452-2015-15911
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Followup
Report Date 09/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC5PO2V
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/15/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
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: 09/10/2015 Patient Sequence Number: 1
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