BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT ASSY V62W AUTOBOX

    MDR report key: 10946654 · Received December 4, 2020

    Report

    Report Number
    2021710-2020-12944
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 9, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZG
    UDI-DI
    10846446021295
    PMA / PMN Number
    K942211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD A SEVERE REACTION WITH THE MOUTHPIECE THAT WAS USED ON THE FIRST DLCO (DIFFUSING CAPACITY FOR CARBON MONOXIDE) DURING SPIROMETRY TEST. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR THREE DAYS DUE TO A SEVERE REACTION THAT CAUSED HIM TO BE SEVERELY SHORT OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414202 INSTRUMENT ASSY V62W AUTOBOX SPIROMETER, DIAGNOSTIC BZG VYAIRE MEDICAL INSTRUMENT ASSY V62W AUTOBOX 10846446021295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention