BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

    MDR report key: 6902670 · Received September 28, 2017

    Report

    Report Number
    2021710-2017-06716
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 7, 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

    VYAIRE COMPLAINT #: (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO EVALUATE THE DEVICE. THE FSR POWERED ON THE DEVICE AND THE ANALYZER BEGAN SMOKING. THE CHIP U10 WAS FOUND BURNING UP. HE REPLACED THE ANALYZER AND TESTED. ALL TO 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 THAT THEY ARE UNABLE TO PERFORM VOLUME, GAS OR BOX CALIBRATION. SHE ATTEMPTED TO LOCATE THE SOURCE OF THE ERROR AND FOUND THREE FUSES BLOWN AND DAMAGE TO THE INTERFACE BOARD. ONE OF THE IC CHIPS ON THE BOARD WAS VISIBLY MELTED. NO PATIENT INVOLVEMENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682462 MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY PLETHYSMOGRAPH, VOLUME JEH VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1