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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 Device Alarm System; Gas output problem ; Out-Of-Box Failure
Event Type  Malfunction  
Manufacturer Narrative

No end user information provided. An rma has been issued but product not returned at the time of this investigation/filing. A follow up will be sent if additional information is received.

 
Event Description

Dealer advised low o2 at 82 percent with no alarm out of the box from order (b)(4) with four hours. Dealer does not indicate whether lack of visual or audible alarm.

 
Manufacturer Narrative

The result of the evaluation was that the o2 levels were within specification and no problem was found, which does not confirm the original complaint issue.

 
Event Description

Dealer advised low o2 at 82 percent with no alarm out of the box from order (b)(4) with four hours. Dealer does not indicate whether lack of visual or audible alarm.

 
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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 Key5108232
Report Number1031452-2015-16098
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/29/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2015
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 Manufacturer09/29/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2015
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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