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

Model Number IRC5PO2V

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The dealer advised that the service tech that went to the patient's home to swap out the unit states that the unit was away from the wall; the exact distance is unknown.The irc5po2v user manual advises to keep the concentrator at least 12 inches away from walls, draperies and furniture.The dealer sent the concentrator to a repair center where the unit was evaluated.It was noted that the unit had no history of maintenance/repairs done by advanced home care.The repair center stated that the front and rear shrouds of the unit were separated, there was evidence of combustion near the top of the sieve bed, and the regulator and product tank cap had separated from the product tank.The concentrator was then returned to invacare for further analysis.The concentrator¿s left sieve bed and pe valve tubing exhibited discoloration and deformation indicative of a melting event.The deformation left holes in the tubing which allowed sieve material to escape into the system and accumulate in the unit¿s base.Additionally, the product tank was displaced, the tank cap was broken, the unit's sound box was visibly bent, and the shroud hinges were damaged.All of this indicated the product tank may have experienced an over-pressurization event, but it appeared the damages were contained within the shroud, despite the broken hinges.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 must experience multiple faults to result in the failure observed.Even though the failure is unlikely to occur, components of the irc5po2v concentrator have been updated to prevent potential recurrence of this issue.The subject concentrator was manufactured prior to implementation of these updates.

Event Description

The dealer reported that the product tank within the irc5po2v concentrator experienced an over-pressurization event, which caused the cabinet door to come off the unit.The cabinet door allegedly hit the wall in the patient's residence, and the cabinet filter stuck to the wall.As a result of the event, the wall was damaged and exhibited black marks near where the concentrator was located.The dealer also stated that the concentrator showed signs of melting at the top of the sieve canister.

• Brand Name: INVACARE PERFECTO2 V OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, 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 Key: 8836467
• MDR Text Key: 207558326
• Report Number: 1031452-2019-00018
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5PO2V
• Device Catalogue Number: IRC5PO2V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1