MAUDE Adverse Event Report: ESSEX INDUSTRIES, INC. PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM; UNIT, LIQUID-OXYGEN, PORTABLE

Model Number	50C-0021-1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The liquid oxygen system failed, ran completely out of oxygen 90 minutes into a patient fixed wing transport with 90 plus minutes of the transport remaining.The patient was on ecmo, so both the ecmo device and ventilator were using oxygen.The crew had to divert the flight to the closest ecmo capable center and manage the patient on a portable oxygen cylinder on the aircraft until met at the airport.The essex industries, inc 10 liter liquid oxygen convertor system had a pressure release valve/vent failure sometime during the course of the transport and lost all oxygen.Sent back to mfg.For repair.

• Brand Name: PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
• Common Device Name: UNIT, LIQUID-OXYGEN, PORTABLE
• Manufacturer (Section D): ESSEX INDUSTRIES, INC.; 8007 chivvis dr; affton MO 63123
• MDR Report Key: 14073321
• Report Number: 14073321
• Device Sequence Number: 2647373
• Product Code: BYJ
• UDI-Device Identifier: 10815363020025
• UDI-Public: 10815363020025
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2022
• Report Date (Section F): 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 50C-0021-1
• Device Catalogue Number: 50C-0021-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 04/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/06/2022