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

Model Number NA:IRC5PO2V

Device Problems Melted (1385); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The reporter stated the device is showing evidence of sparking/melting on the pe valve and tubing connected to the pe valve.

Manufacturer Narrative

This incident is being reported to the fda based on the evidence that the device experienced an over-pressurization event of the product tank, an overheating event, or a possible precursor to such events.This failure mode resembles that which has been previously identified and investigated.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.This issue also resulted in a field correction (z-0514-2021) to replace the pe valve assembly in impacted irc5po2v concentrators to reduce the potential for a failure that can, in infrequent instances, result in a short duration and self-extinguishing thermal reaction.The subject concentrator falls within the scope of this field correction.This device was over 4 years old at the time of this incident which is past the 3 year service life.It was requested that the concentrator be returned to invacare for inspection.If a different root cause is determined, a supplemental record will be filed.

• Brand Name: PERFECTO2 V WITH SENSOR 9153650799
• 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 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 14787123
• MDR Text Key: 303292574
• Report Number: 1031452-2022-00032
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NA:IRC5PO2V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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