BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC CHAMBER

    MDR report key: 6393331 · Received March 9, 2017

    Report

    Report Number
    2020676-2017-00003
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 23, 2016
    Report Date
    February 23, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECHRIST TECHNICIAN WAS DISPATCHED ONSITE ON 2/26/2016. TECHNICIAN PERFORMED MAX PRESSURE TEST, CHECKED/INSPECTED CONTROL PANEL TUBINGS AND OTHER COMPONENTS FOR POSSIBLE LEAKS. PERFORMED CHAMBER CONTROL SYSTEM CALIBRATION IAW SECTION 11.5 (ELECTRONIC CONTROL MODULE MANUAL). PERFORMED & COMPLETED OPERATIONAL/VERIFICATION. (B)(4) STAFF AND TECHNICIAN RAN CHAMBER FOR 90 MINUTES W/RS OF 1.5 & PS OF 2.4 ATA, CHAMBER MAINTAINED PRESSURE FOR DURATION OF TEST. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING AND FOUND NO NONCONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HYPERBARIC CHAMBER PRESSURE DROPS FROM 2.4ATA TO 2.3ATA. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175670 HYPERBARIC CHAMBER CHAMBER, HYPERBARIC CBF SECHRIST INDUSTRIES, INC. 3600ER

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR