BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIGH FREQUENCY JET VENTILATOR

    MDR report key: 537883 · Received July 12, 2004

    Report

    Report Number
    537883
    Event Type
    Other
    Date Received
    July 12, 2004
    Date of Event
    May 20, 2004
    Report Date
    June 23, 2004
    Manufacturer
    BUNNELL INC.
    Product Code
    LSZ
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICU VENTILATOR SUDDENLY FAILED. THE SCREEN LOOKED AS IF THE VENTILATOR REVERTED TO A TEST MODE. THE PT WAS MANUALLY VENTILATED. THERE WAS NO HARM TO THE PT. THIS VENTILATOR HAD PREVENTATIVE MAINETANCE PERFORMED BY THE MFR. IT HAD ONLY BEEN RETURNED A COUPLE OF WEEKS WHEN THIS EVENT OCCURRED. INITIALLY THE CO SAID THE PROBLEM WAS USER ERROR. AFTER FURTHER INVESTITATION, IT WAS DISCOVERED THAT COMPONENTS IN THE ELECTRONICS OF THE DEVICE CORRODED. SPECIFICALLY, THESE COMPONENTS ARE INTERFACE CONNECTORS ON THE HFV DRIVER PCB AND HFV PROCESSOR PCB ASSEMBLIES. THESE CORRODED COMPONENTS WERE MADE OF TIN AND LEAD. THE CURRENT INDUSTRY STANDARD IS GOLD. IT IS NOT PART OF PREVENTATIVE MAINTENANCE TO CHECK THESE CONNECTORS. ACCORDING TO THE MFR, THERE ARE CURRENTLY APPROX 400 VENTILATORS IN SERVICE. AT THIS TIME, THE MFR IS TRYING TO DETERMINE HOW MANY OF THESE DEVICES HAVE CONNECTORS CONSTRUCTED OF TIN AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY JET VENTILATOR VENTILATOR LSZ BUNNELL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other