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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problems Overheating of Device; Explosion
Event Type  Malfunction  
Manufacturer Narrative

The allegation that the product tank cap released sharp metal pieces is inaccurate; the product tank cap is composed of nylon (plastic), not metal. The concentrator was returned to invacare and was evaluated. It was confirmed that the unit exhibited damage to the product tank and shroud, as was alleged. The product tank was returned detached from the concentrator assembly and the tank cap was broken into a number of small fragments. The shroud hinges were broken, the sound box was visibly bent, and the control panel was cracked above the intended location of the product tank. All of this indicated the product tank experienced an over-pressurization event. However, it could not be determined with certainty whether any components escaped the shroud during the event. Additionally, the concentrator's pe valve tubing was damaged and discolored in the vicinity of the left sieve bed cap. This failure mode has been previously identified and investigated. The investigation activities concluded that the failure is unlikely to occur when the system is operating under normal conditions or a single fault condition. Rather, the system likely has to experience multiple faults to result in the failure observed. Even though the failure is unlikely to occur, the concentrator's components are being updated to prevent potential recurrence of this issue.

 
Event Description

The provider reported that the irc5po2v concentrator made a loud noise, and it was discovered that the product tank seal had burst and punctured through the top shroud, which damaged the hour meter and sound box. He alleged that the metal casing of the product tank cap shot through the top shroud, sending sharp metal into the room. The provider advised that the unit is a rental and was in a patient's home when the incident occurred, but no injuries or property damage resulted from the event.

 
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Brand NameINVACARE PERFECTO2 V OXYGEN CONCENTRATOR
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 Key8273945
Report Number1031452-2019-00002
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2019
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC5PO2V
Device Catalogue NumberIRC5PO2V
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/02/2018
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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