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 Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The dealer advised that they inspected the concentrator and found that the shroud was separated at the seams but was still secured to the base of the unit.Also, they did not notice any evidence of overheating on the exterior of the device.The dealer stated that there was no injury or damage to the home as a result of the incident.The concentrator was returned to invacare.Through visual inspection of the device, it appeared that the product tank had experienced an over-pressurization event.It was observed that the plastic product tank cap had fragmented, and there was deformation to the sound box where the product tank was located.It was also observed that the cabinet retainer clips and screws at the bottom of the cabinet became disconnected, so the front and rear shrouds were separated, but the upper attachments points remained intact, so the shrouds did not fully detach.The tubing located near the pe valve and sieve bed caps was discolored, and sieve material was present at multiple locations within the device.This incident is being reported to the fda out of an abundance of caution, based on the evidence from the evaluation that the product tank experienced an over-pressurization event.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, 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

Per the dealer, the end user alleged that while she was using the irc5po2v concentrator in her home, her husband heard a loud bang noise.When he went to check what was going on, he allegedly saw smoke coming from the concentrator and a red glow in the cracks where the filter is located on the back of the unit.

• 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: 9316662
• MDR Text Key: 207559755
• Report Number: 1031452-2019-00031
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 11/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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