BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 21289171 · Received January 31, 2025

    Report

    Report Number
    2020676-2025-00007
    Event Type
    Death
    Date Received
    January 31, 2025
    Date of Event
    January 31, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    CBF
    UDI-DI
    00852682007637
    PMA / PMN Number
    K140559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED SOLELY ON THE AVAILABLE INFORMATION AT THIS TIME. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION BY THE (B)(6), MICHIGAN OFFICIALS AND SECHRIST HAS NOT YET BEEN OFFICIALLY NOTIFIED. AT THIS TIME, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OR IF ANY DEVICE MALFUNCTION OCCURED. MANUFACTURER REFERENCE FILE NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS WILL SUPPLEMENT THE INFORMATION SUBMITTED ON JANUARY 31, 2025 (SAME DAY OF THE INCIDENT), (B)(6) 2025 REGARDING THE INCIDENT THAT INCURRED AT (B)(6) IN (B)(6), INVOLVING A SECHRIST MODEL 3300HR HYPERBARIC CHAMBER IDENTIFIED BY S/N (B)(6). ON JUNE 26, 2025, A REPRESENTATIVE OF SECHRIST ATTENDED AN INSPECTION OF THE SECHRIST MODEL 3300HR HYPERBARIC CHAMBER IDENTIFIED BY S/N (B)(6). THE INSPECTION WAS ATTENDED BY COUNSEL REPRESENTING INDIVIDUALS AGAINST WHOM CRIMINAL CHARGES HAVE BEEN FILED IN THE STATE OF MICHIGAN. THE INSPECTION WAS ATTENDED BY COUNSEL REPRESENTING THE (B)(6) FAMILY, THE (B)(6) CENTER AND THE PROPERTY OWNER / MANAGER, THE CITY OF (B)(6) (CIVIL PARTIES). THE INSPECTION WAS ATTENDED BY CONSULTANTS RETAINED BY THE PARTIES. THE INSPECTION WAS CONDUCTED PURSUANT TO A JUNE 23, 2025 ORDER OF THE HONORABLE (B)(6) IN THE CIRCUIT COURT FOR THE COUNTY OF (B)(6) (CASE NO (B)(6)) THAT LIFTED A PRIOR RESTRAINING ORDER ON THE PREMISES AND PERMITTED THE INSPECTION. REPRESENTATIVES OF THE (B)(6) FIRE DEPARTMENT HOSTED THE INSPECTION. THE CONSULTANTS RETAINED BY THE PARTIES TOOK PHOTOS OF THE INCIDENT SCENE AND SUBJECT SECHRIST MODEL 3300HR HYPERBARIC CHAMBER. THE INSPECTION INCLUDED 3D SCANS OF THE INCIDENT SCENE AND PORTIONS OF THE SECHRIST MODEL 3300HR HYPERBARIC CHAMBER. THE INSPECTION INCLUDED TESTING OF THE GROUNDING OF THE SUBJECT SECHRIST MODEL 3300HR HYPERBARIC CHAMBER AND TESTING OF THE CIRCUITS IN THE SUBJECT SECHRIST MODEL 3300HR HYPERBARIC CHAMBER. SECHRIST REPRESENTATIVE DID NOT IDENTIFY ANY EVIDENCE THAT THERE WAS A GROUNDING STRAP IN THE SUBJECT AT THE TIME OF THE INCIDENT. SECHRIST REPRESENTATIVE CONDUCTED THE TESTING OF THE CIRCUITS OF THE SUBJECT SECHRIST MODEL 3300HR HYPERBARIC CHAMBER. SECHRIST REPRESENTATIVE DID NOT IDENTIFY ANYTHING WRONG WITH ANY OF THE CIRCUITS OF THE SUBJECT SECHRIST MODEL 3300HR HYPERBARIC CHAMBER. THE SUBJECT SECHRIST MODEL 3300HR HYPERBARIC CHAMBER AND ARTIFACTS FROM THE INCIDENT INCLUDING THE STRETCHER PLATE AND TEXTILES ON THE STRETCHER PLATE ARE BEING PRESERVED BY THE PARTIES FOR FUTURE LAB TESTING PURSUANT TO A PROTOCOL TO BE AGREED UPON. MANUFACTURER REFERENCE FILE NO.: (B)(6).

    Description of Event or Problem · 0

    ON JANUARY 31, 2025, SECHRIST BECAME AWARE OF A DEATH, TO A CHILD, THAT WAS BEING TREATED IN A HYPERBARIC CHAMBER. OFFICIALS IN (B)(6), MICHIGAN CONFIRMED A CHILD DIED AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177061 SECHRIST INDUSTRIES INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES INC. 3300H-00 00852682007637

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Death