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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 Defective Alarm; Defective Component; Switch, Push Button
Event Type  Malfunction  
Event Description

This unit is not alarming due to a defective on/off switch. Dealer states unit is getting 2 green 1 red light error code from the pcb.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

The device was evaluated by the returns department which found that the compressor is noisy and the no alarm was not confirmed.

 
Event Description

This unit is not alarming due to a defective on/off switch. Dealer states unit is getting 2 green 1 red light error code from the pcb.

 
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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 Key4915959
Report Number1031452-2015-14883
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type Distributor,DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 08/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2015
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 Manufacturer08/03/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2015
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: 07/15/2015 Patient Sequence Number: 1
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