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U.S. Department of Health and Human Services

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

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INVACARE FLORIDA PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number NA:IRC5PO2V
Device Problems Material Discolored; Material Deformation; Explosion
Event Type  Malfunction  
Manufacturer Narrative

The device was manufactured in march 2017 making it roughly 1 year and 10 months old at the time of the event. This device has an expected life of 3 years. The device is currently in the process of being returned to invacare for investigation. Pictures were provided which showed: the product tank cap which is composed of nylon (plastic) appeared to be broken into pieces, the pressure regulator appeared to be damaged, and discoloration and deformation of the tubing coming from the sieve beds was visible. Based on the available information this failure mode appears to have been previously identified and investigated. The investigation activities concluded that the failure is unlikely to occur, the system must experience multiple faults to result in the failure observed. When the system is operating under normal conditions or a single fault condition the failure is unlikely. Invacare has updated the concentrator's components to prevent potential recurrence of this issue. An update will be provided if any new information is obtained.

 
Event Description

The reporter stated the top of the product tank and the pressure regulator had come off in pieces causing the cabinet casing to break into two pieces, and sieve dust was throughout the unit. The end user was not in the room at the time, and no injury was alleged. The unit was a rental unit.

 
Manufacturer Narrative

Further inspection was completed on the irc5po2v concentrator. The evaluation confirmed the allegation that the product tank was involved in an over-pressurization event. The product tank cap was fragmented, and the sound box was deformed. The pe valve tubing was discolored and had a hole present indicating the tubing experienced an overheating event. The shroud was fractured along the seam and the control panel, hour meter, and power switch were displaced. The evidence supports this event was contained within the shroud of the concentrator. Based on the available information this failure mode appears to have been previously identified and investigated. The investigation activities concluded that the failure is unlikely to occur, the system must experience multiple faults to result in the failure observed. When the system is operating under normal conditions or a single fault condition the failure is unlikely. Invacare has updated the concentrator's components to prevent potential recurrence of this issue.

 
Event Description

The reporter stated the top of the product tank and the pressure regulator had come off in pieces causing the cabinet casing to break into two pieces, and sieve dust was throughout the unit. The end user was not in the room at the time, and no injury was alleged. The unit was a rental unit.

 
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Brand NamePERFECTO2 V WITH SENSOR 9153650799
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
jason fiest
one invacare way
elyria , OH 44035
8003336900
MDR Report Key8429229
Report Number1031452-2019-00005
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 02/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2019
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberNA:IRC5PO2V
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/09/2017
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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