Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/12/2020
Event Type  malfunction  
Manufacturer Narrative
Photographs of the concentrator were provided, which show discoloration of the cabinet's exterior near the inlet filter and cabinet filter door.Also, remnants of the cabinet filter are present on the filter door.The dealer stated that the unit was used at night on setting 3.It was positioned in the center of the laundry room, which had ventilation.The dealer tested the outlet that the unit was plugged into, and he stated it was good.The dealer advised that the end user does not smoke, nor does anyone else in the home.The dealer indicated that the unit is a rental and was provided to the end user on (b)(6) 2019.He stated that they do not perform maintenance on the unit, but the bacterial filter was replaced and the other filters were cleaned before the unit was provided to the end user.The unit was also tested for oxygen purity.This incident is being reported to the fda out of an abundance of caution, based on the evidence that the overheating event exited the shroud.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.The concentrator was returned to invacare and is pending further evaluation.Once the evaluation results are available, a supplemental record will be filed.
 
Event Description
The dealer reported that the end user alleged they heard a loud bang which woke them, and they found that the irc5po2v concentrator had caught on fire.The dealer indicated that the fire started internally and came out through the cabinet filter door.The dealer alleged the cabinet filter melted and dripped down, causing damage to the end user's floor.The end user was not injured.
 
Manufacturer Narrative
The evaluation of the concentrator was completed on (b)(6)2020.It was observed that the concentrator's pe valve and sieve tubing exhibited dark discoloration and deformation.Additional dark discoloration was noted around the rear shroud's filter cabinet, concentrated in the vicinity of the left sieve bed cap.These observations suggest that the unit experienced an internal overheating event, as was alleged.
 
Event Description
The dealer reported that the end user alleged they heard a loud bang which woke them, and they found that the irc5po2v concentrator had caught on fire.The dealer indicated that the fire started internally and came out through the cabinet filter door.The dealer alleged the cabinet filter melted and dripped down, causing damage to the end user's floor.The end user was not injured.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key9671298
MDR Text Key178374950
Report Number1031452-2020-00003
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
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 Manufacturer01/31/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-