MAUDE Adverse Event Report: HYPERBARIC CHAMBER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 07/08/2018

Event Type  Death  

Event Description

My brother was in the hospital medical center in (b)(6), and his fingers were burned and because his health was.Based the hospital refused to treat him with the hypobaric chamber and told him he was not healthy enough to participate with the treatment of the hypobaric chamber.But because of my brother (b)(6)'s many requests and then they allowed him to take part in the treatment.And he died leaving the chamber, his lungs gave out and he went into cardiac arrest and died.

• Brand Name: HYPERBARIC CHAMBER
• Type of Device: HYPERBARIC CHAMBER
• MDR Report Key: 7713784
• MDR Text Key: 114947768
• Report Number: MW5078516
• Device Sequence Number: 0
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 109