BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERBARIC CHAMBER

    MDR report key: 5855494 · Received August 8, 2016

    Report

    Report Number
    2020676-2016-00005
    Event Type
    Death
    Date Received
    August 8, 2016
    Date of Event
    August 22, 2015
    Report Date
    March 15, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    PMA / PMN Number
    K140559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECHRIST MADE SEVERAL ATTEMPTS TO TRY AND OBTAIN THE CHAMBER FOR EVALUATION. SEVERAL PHONE CALLS WERE MADE TO DR. (B)(6) AT (B)(6) AND MESSAGES WERE NEVER RETURNED. BASED ON DEVICE HISTORY REVIEW, THIS CHAMBER WAS IN USE BEYOND THE CURRENT PVHO REGULATED CYLINDER LIFE OF 20 YEARS AND WAS MANUFACTURED IN 1989. THIS HYPERBARIC CHAMBER WAS ORIGINALLY SOLD TO (B)(6) HOSPITAL AND SECHRIST CONDUCTED ANNUAL PREVENTATIVE MAINTENANCE THROUGH 1998. AT NO TIME WAS SECHRIST MADE AWARE OF RELOCATION OF THIS CHAMBER TO ANY OTHER FACILITY. (B)(6) FIRE INVESTIGATION STATED THAT DR. (B)(6) PURCHASED THE CHAMBER ON (B)(6). BASED ON (B)(6) FIRE INVESTIGATIONS SECHRIST INDUSTRIES ALSO LEARNED THAT DR. (B)(6) PLACED A BATTERY OPERATED FAN IN THE CHAMBER WHILE IN USE. INTRODUCTION OF ANY TYPE OF HEAT SOURCE INTO A HYPERBARIC CHAMBER IS STRICTLY AGAINST MANUFACTURER RECOMMENDATIONS AS WELL AS NFPA99 HEALTH CARE FACILITIES CODE, CHAPTER 14 HYPERBARIC FACILITIES. : DEVICE NOT PROVIDED FOR EVALUATION.

    Description of Event or Problem · 1

    SECHRIST INDUSTRIES RECEIVED AN EMAIL FROM (B)(6) WITH (B)(6) NEWS STATING THAT THEY WOULD BE AIRING A STORY ABOUT A FIRE THAT TOOK PLACE INSIDE A HYPERBARIC CHAMBER AT (B)(6). REPORTEDLY, (B)(6) BROUGHT HER DOG TO THE VETERINARIAN CLINIC WHERE DR. (B)(6) GAVE THE DOG OXYGEN THERAPY BY PUTTING THE DOG INSIDE A HYPERBARIC CHAMBER. DURING THERAPY THE CHAMBER CAUGHT ON FIRE, KILLING THE DOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505696 HYPERBARIC CHAMBER HYPERBARIC CHAMBER CBF SECHRIST INDUSTRIES, INC. 2500B/BR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death