MAUDE Adverse Event Report: ENVIRONMENTAL TECTONICS CORP. BARA-MED; CHAMBER, HYPERBARIC

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2016

Event Type  malfunction  

Event Description

When the technician went to close the door to the chamber and begin the patient's treatment, the handle broke off and the patient was trapped in the chamber.The technician called the clinical coordinator and the program manager immediately.Maintenance was called and the patient was removed from the chamber after 20 minutes of being in there.The manufacturer will also be called in to make sure that the machine is safe for patient use before we resume treatments.Manufacturer response for hyperbaric chamber, hyperbaric chamber (per site reporter): notified and evaluated chamber.

• Brand Name: BARA-MED
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): ENVIRONMENTAL TECTONICS CORP.; 125 james way; southampton PA 18966
• MDR Report Key: 6036511
• MDR Text Key: 57734476
• Report Number: 6036511
• Device Sequence Number: 1
• Product Code: CBF
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR