BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERSCREEN

    MDR report key: 14492529 · Received May 24, 2022

    Report

    Report Number
    9615102-2022-00123
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    April 26, 2022
    Report Date
    April 26, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZC
    PMA / PMN Number
    K122699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). THE PNEUMOTACH OVERHEATING IN THE BOX WAS FOUND TO BE DEFECTIVE AND WILL NOT BE RETURNED TO VYAIRE MEDICAL FOR ANALYSIS. VYAIRE MEDICAL WILL BE REPLACED THE DEFECTIVE PART AS ORDERED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION WAS RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PNEUMOTACH OVERHEATING WITHIN THE JAEGAR BODY BOX. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114702 MASTERSCREEN CALCULATOR, PULMONARY FUNCTION DATA BZC VYAIRE MEDICAL OBS, MASTERSCREEN PFT ESSENTIAL WITH BODY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown