BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

    MDR report key: 6902880 · Received September 28, 2017

    Report

    Report Number
    2021710-2017-06718
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    July 17, 2017
    Report Date
    January 8, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    JEH
    PMA / PMN Number
    K072061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR DETERMINED THAT THE BOX CALIBRATION COULD NOT BE PERFORMED. CONSTANT 'CLOSE DOOR' ERROR MESSAGE APPEARS AND A BURNING SMELL WAS NOTICED. HE LOCALIZED THE ISSUE TO THE INTERFACE CARD WHERE AN IC CHIP ON THE CARD BEGAN TO MELT. A REPLACEMENT CARD WAS INSTALLED AND THE DEVICE MEETS ALL FACTORY SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INITIAL SUBMISSION THE FAILURE INVESTIGATION REPORT WAS NOT INCLUDED. RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SYSTEM BOX HOWEVER NO INVESTIGATION COULD BE PERFORMED DUE TO THE PART BEING RETURNED IMPROPERLY PACKAGED, WITHOUT A COVER OR AN ELECTRO-STATIC DISCHARGE BAG, COMPROMISING THE FUNCTIONALITY OF THE PCBAS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE IMPULSE OSCILLOMETER (IOS) THAT IS CONNECTED TO THE SYSTEM IS GETTING GENERAL INITIALIZATION FAILED, IOS NOT FOUND. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT OR HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682301 MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY PLETHYSMOGRAPH, VOLUME JEH VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1