• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO 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
 

RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1020011
Device Problem Electrical Shorting
Event Date 06/04/2019
Event Type  Malfunction  
Event Description

The manufacturer received information alleging an everflo oxygen concentrator had evidence of damage to the power cord and emitted sparks. There was no report of patient harm or injury. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be submitted when the manufacturer has completed the investigation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVERFLO OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer (Section G)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
Manufacturer Contact
adam price
312 alvin drive
new kensington , PA 15068
7243349303
MDR Report Key8758177
Report Number1040777-2019-00032
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 06/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number1020011
Device Catalogue Number1020011
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-