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 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The concentrator was returned to invacare.Through visual inspection, it was confirmed that the unit exhibited evidence that the product tank cap had experienced an over-pressurization event.It was observed that the product tank cap was fragmented, there was deformation to the sound box and an indentation of the cabinet near where the product tank was positioned, and the front and rear shrouds had begun to separate.In addition to the damage sustained at the product tank, it was observed that the tubing connected to the pe valve and check valves sustained discoloration, and there was sieve material present within the tubing.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

A repair center reported that they received an irc5po2v concentrator with a tag that stated the unit had blown up, but there was no harm to the end user and no property damage.They advised that everything was contained within 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: 9417880
• MDR Text Key: 207567411
• Report Number: 1031452-2019-00108
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• 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