MAUDE Adverse Event Report: VERO 270 2.0ATA HARD SIDED SITTING HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC

Model Number	VERO 270 2.0ATA HARD SIDED SITTI
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received on 11/24/2025 for report mw5176289 to update the manufacturer.This is to replace my prior report (mw5176289 submitted on 9/16/25), which somehow lists the wrong manufacturer as typhoon water wares.I was informed by the patient involved that she had procured the chamber from a company in or near (b)(6).This was per a phone conversation with the involved patient.Vero 270 2.0ata hard sided sitting hyperbaric chamber got called about a hyperbaric chamber incident occurring on (b)(6) 2025 with the above model.Somewhere near (b)(6).I tracked the patient down and spoke with her.The patient had the door blow off her chamber that was in her home when pressurized to nearly at nearly 2 ata (14.7 psig).Reportedly, the only injury was to her leg from the door hitting her.She's a nurse practitioner treating herself for mastectomy wound recovery from breast cancer.She wants to add this modality to her office practice.The door blew out at ~2ata without issue except blunt force to her leg from the hatch.She thinks the chamber atmosphere was about 32% o2 and 90% to her via mask or cannula.
Event or Problem Description
Additional information received on 01/12/2026 for report mw5176289 to update the manufacturer.
Event or Problem Description
Vero 270 2.0ata hard sided sitting hyperbaric chamber got called about a hyperbaric chamber incident occurring on (b)(6) 2025 with the above model.Somewhere near (b)(6).I tracked the patient down and spoke with her.The patient had the door blow off her chamber that was in her home when pressurized to nearly at nearly 2 ata (14.7 psig).Reportedly, the only injury was to her leg from the door hitting her.She's a nurse practitioner treating herself for mastectomy wound recovery from breast cancer.She wants to add this modality to her office practice.The door blew out at ~2ata without issue except blunt force to her leg from the hatch.She thinks the chamber atmosphere was about 32% o2 and 90% to her via mask or cannula.
Event or Problem Description
Additional information received on 01/21/2026 for report mw5176289 to update the manufacturer to unknown in the file name.E3: unk.

• Brand Name: VERO 270 2.0ATA HARD SIDED SITTING HYPERBARIC CHAMBER
• Common Device Name: CHAMBER, HYPERBARIC
• MDR Report Key: 23109677
• Report Number: MW5176289
• Device Sequence Number: 13072207
• Product Code: CBF
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2025
• Device Model Number: VERO 270 2.0ATA HARD SIDED SITTI
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/25/2025; 01/12/2026; 01/22/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White