inforMED
MalfunctionCBF

VERO 270 2.0ATA HARD SIDED SITTING HYPERBARIC CHAMBER

Received Sep 22, 2025 · Event occurred Sep 9, 2025

Report MW5176289 · MDR key 23109677

Device

Generic name

Chamber, Hyperbaric

Manufacturer

Unk

Product problems

  • Burst Container or Vessel

Patient

48 YR · Female

  • Unspecified Tissue Injury
  • Unspecified Tissue Injury

Narrative

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 01/21/2026 FOR REPORT MW5176289 TO UPDATE THE MANUFACTURER TO UNKNOWN IN THE FILE NAME. E3: UNK.

Description of Event or Problem

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.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 01/12/2026 FOR REPORT MW5176289 TO UPDATE THE MANUFACTURER.

Description of Event or Problem

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.