BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERO 270 2.0ATA HARD SIDED SITTING HYPERBARIC CHAMBER

    MDR report key: 23109677 · Received September 22, 2025

    Report

    Report Number
    MW5176289
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 16, 2025
    Manufacturer
    UNK
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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 · 0

    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 · 0

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

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201671 VERO 270 2.0ATA HARD SIDED SITTING HYPERBARIC CHAMBER CHAMBER, HYPERBARIC CBF UNK VERO 270 2.0ATA HARD SIDED SITTI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female