MAUDE Adverse Event Report: MEDCYL OXYGEN COMPRESSED GAS E-CYLINDER

Lot Number 1180681

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.

• Brand Name: OXYGEN COMPRESSED GAS E-CYLINDER
• Type of Device: OXYGEN COMPRESSED GAS E-CYLINDER
• Manufacturer (Section D): MEDCYL; 4236 n orange blossom trail; orlando FL 32804
• MDR Report Key: 7633578
• MDR Text Key: 112174411
• Report Number: 7633578
• 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: User Facility
• Reporter Occupation: Other
• 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 Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1180681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Distributor Facility Aware Date: 04/23/2018
• Event Location: Home
• Date Report to Manufacturer: 04/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER ADAPTER ; NEB KIT, AEROSOL MASK ; NEBULIZER ; O2 CART; OCD; OCD POUCH; OXYGEN WRENCHS; REGULATOR
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 80 YR
• Patient Weight: 54