BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENT, HBO, MODEL HV-500A

    MDR report key: 680709 · Received February 24, 2006

    Report

    Report Number
    2020676-2006-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2006
    Date of Event
    February 1, 2006
    Report Date
    February 24, 2006
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENT STOPPED WORKING WHEN THE HYPERBARIC CHAMBER PRESSURE WAS BETWEEN 18 AND 22 PSI. TECHNICIANS STOPPED HBO THERAPY AND REMOVED PT WITHOUT INCIDENT. CUSTOMER STATED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENT, HBO, MODEL HV-500A HYPERBARIC VENTILATOR CBK SECHRIST INDUSTRIES, INC. 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention