BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERSCREEN

    MDR report key: 10841278 · Received November 14, 2020

    Report

    Report Number
    9615102-2020-00116
    Event Type
    Malfunction
    Date Received
    November 14, 2020
    Date of Event
    May 15, 2020
    Report Date
    May 15, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VYAIRE MEDICAL DETERMINED THAT THE ROOT CAUSE OF THE BURNING SMELL IS A DEFECTIVE ELECTRICAL OF MS SYSTEMBOX 115V (110V/125V), 430MM. TO ADDRESS THE REPORTED ISSUE, THE COMPONENT HAS BEEN REPLACED. THE UNIT WAS TESTED AND PASSED ALL TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT WHEN UNIT WAS POWERED ON THERE WAS A DISTINCTIVE SMELL OF BURNING COMING FROM MS PFT RT SES WITH PC. THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306365 MASTERSCREEN CALCULATOR, PULMONARY FUNCTION DATA BZC VYAIRE MEDICAL MS PFT RT SES WITH PC

    Patients

    Seq Age Sex Outcome Treatment
    1