BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALVE, PRESSURE RELIEF

    MDR report key: 827461 · Received February 6, 2007

    Report

    Report Number
    2020676-2007-00002
    Event Type
    Other
    Date Received
    February 6, 2007
    Date of Event
    October 30, 2006
    Report Date
    February 6, 2007
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO VERIFY CUSTOMER'S COMPLAINT THAT SPINDLE OF PRESSURE RELIEF VALVE UNWOUD DURING USE. NO PROBLEM COULD BE FOUND, VISUALLY OR MECHANICALLY. IT APPEARS TO BE USER ERROR. USER ADVISED BY FIELD REP TO READ AND FOLLOW INSTRUCTONS FOR USE.

    Description of Event or Problem · 1

    ADJUSTMENT SPINDLE UNWOUND DURING HBO TREATMENT REPORTEDLY DUE TO PT COUGHING. TREATMENT IN HBO CHAMBER CONTINUED AS PT WAS BREATHING SPONTANEOUSLY. NO PT INJURY COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALVE, PRESSURE RELIEF * CBP SECHRIST INDUSTRIES, INC. IV-317K *

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR