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: AIRSEP (CHART INDUSTRIES) NEW LIFE INTENSITY; OXYGEN CONCENTRATOR
  • 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
 

AIRSEP (CHART INDUSTRIES) NEW LIFE INTENSITY; OXYGEN CONCENTRATOR Back to Search Results
Model Number AS099-100
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Burn, Thermal (2530)
Event Date 01/19/2017
Event Type  Death  
Event Description
(b)(6) was notified at 20:24 on (b)(6) 2017 by (b)(6) police officer that patient was deceased due to a fire in her home.The cause of the incident is under investigation by (b)(6) state fire marshal.The bureau of fire and arson investigation indicates that it is with high probability that smoking while wearing the nasal cannula with 100 percent oxygen flowing at 5 liters/minute caused the nasal cannula to ignite.There was no indication or signs of any other medical equipment in the area of origin or as a cause of this fire.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NEW LIFE INTENSITY
Type of Device
OXYGEN CONCENTRATOR
Manufacturer (Section D)
AIRSEP (CHART INDUSTRIES)
401 creekside dr.
buffalo NY 14228
MDR Report Key6326922
MDR Text Key67289649
Report Number6326922
Device Sequence Number1
Product Code CAW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberAS099-100
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2017
Distributor Facility Aware Date01/19/2017
Device Age5 YR
Event Location Home
Date Report to Manufacturer01/25/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/25/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
M CYLINDER WITH STAND DELIVERED ; M6 CYLINDER; OVER BED TABLE ; PORTABLE CONCENTRATOR
Patient Outcome(s) Death;
Patient Age69 YR
Patient Weight87
-
-