BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES, INC.

    MDR report key: 6307045 · Received February 7, 2017

    Report

    Report Number
    6307045
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    February 23, 2016
    Report Date
    December 28, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NO HARM TO PATIENT. PATIENT SAFELY REMOVED FROM CHAMBER. CHAMBER#1 S/N 360196 NOT HOLDING PRESSURE AT DEPTH OF 2.4 ATA/20.58 PSIG. NO SYSTEM ALARM. ONLY NORMAL SOUNDS THAT OCCUR DURING CHAMBER OPERATION. NOTIFIED SERENA GROUP AS SOON AS DISCREPENCY DISCOVERED. MANAGER NOTIFIED. EMERGENCY CALL PLACED TO SECHRIST (B)(4). SECHRIST TO SEND SERVICE TECHNICIAN. "OUT OF ORDER" SIGN PLACED ON CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90071 SECHRIST INDUSTRIES, INC. CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES, INC. 3600ER-00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR