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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 Circuit Board; Device Alarm System; Electrical Shorting
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Dealer states the circuit board is burnt and the unit wont alarm. Dealer was advised to clarify. He only stated burnt and didn't specify anything else. Dealer elaborated stating: "sorry, i am glad you asked, i misunderstood that myself. Burnt meaning he thinks something short circuited but not burnt as in appearance or fire. ".

 
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 pcb had an open resistor causing the unit to shut down, which confirmed the original complaint issue. However, there is no indication of a failure of the alarms.

 
Event Description

Dealer states the circuit board is burnt and the unit won't alarm. Dealer was advised to clarify. He only stated burnt and didn't specify anything else. Dealer elaborated stating: "sorry, i am glad you asked, i misunderstood that myself. Burnt meaning he thinks something short circuited but not burnt as in appearance or fire. ".

 
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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 Key5373937
Report Number1031452-2016-00156
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Repair
Type of Report Followup
Report Date 01/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/18/2016
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 Manufacturer01/22/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
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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