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

MAUDE Adverse Event Report: MEDCYL OXYGEN COMPRESSED GAS M6 TANK

  • 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
 

MEDCYL OXYGEN COMPRESSED GAS M6 TANK Back to Search Results
Lot Number 1180955
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 04/20/2018
Event Type  Death  
Event Description

(b)(6) sw made visit on (b)(6) 2018 and was notified by (b)(6) that pt was airlifted to (b)(6) on (b)(6) 2018 due to burns on face and arms. (b)(6) states pt turned off o2 but didn't wait to smoke. Spoke with operator at (b)(6) who confirmed pt admit date (b)(6) 2018 and death date (b)(6) 2018. Local police report stated that pt was injured by minor explosion/fire and suffered third degree burns. Either oxygen e tank or m6 tank was involved in pt injury/death, unable to ascertain for sure because we are unable to enter home to investigate equipment. Ref uf# (b)(4) for oxygen cylinder m6 tank.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOXYGEN COMPRESSED GAS M6 TANK
Type of DeviceOXYGEN COMPRESSED GAS M6 TANK
Manufacturer (Section D)
MEDCYL
4236 n orange blossom trail
orlando FL 32804
MDR Report Key7633603
MDR Text Key112177383
Report Number7633603
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2018
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device LOT Number1180955
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2018
Distributor Facility Aware Date04/23/2018
Event Location Home
Date Report TO Manufacturer04/27/2018
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/27/2018 Patient Sequence Number: 1
Treatment
HUMIDIFIER ADAPTER; NEB KIT, AEROSOL MASK; NEBULIZER; O2 CART; OCD; OCD POUCH; OXYGEN WRENCHES; REGULATOR
-
-