BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VAPORIZER

    MDR report key: 1634267 · Received March 12, 2010

    Report

    Report Number
    9610531-2010-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 10, 2010
    Manufacturer
    PENLON LTD.
    Product Code
    CAD
    PMA / PMN Number
    CLASS 2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON INVESTIGATION PENLON BELIEVE THAT A SOLID, CORROSIVE, FOREIGN BODY WAS INTRODUCED INTO THE SYSTEM VIA THE GAS FLOW PATH THROUGH THE BACK BAR. THIS WAS THEN CARRIED DOWN TO THE TEMPERATURE COMPENSATION DEVICE AND THE CONTROL NEEDLE, CAUSING MECHANICAL AND CORROSIVE DAMAGE. WITH THESE TWO PARTS AFFECTED CONTROL OF THE VAPORIZER WOULD BE COMPROMISED. A CHANGE IN THE PERFORMANCE OF THE VAPORIZER WOULD BE PICKED UP VIA THE PATIENT MONITORING. THE HEALTHCARE PROFESSIONAL WOULD HAVE SET THE ALARM LEVELS FOR THE ANAESTHETIC AGENT AND THEREFORE, IF THE DEVICE DELIVERED AGENT ABOVE OR BELOW THE REQUIRED LEVELS, THE ALARM WOULD SOUND. THIS WOULD ALLOW ACTION TO BE TAKEN TO AVOID DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PENLON DELTA VAPORIZER OVER-DELIVERED ANAESTHETIC AGENT WHILST BEING USED ON A PATIENT. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY. THE VAPORIZER WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VAPORIZER ANESTHETIC VAPORIZER CAD PENLON LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1