BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLENDER

    MDR report key: 9344327 · Received November 19, 2019

    Report

    Report Number
    2021710-2019-11049
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BZR
    UDI-DI
    10846446002256
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT #: (B)(4). ADDITIONAL INFORMATION: G4, G7, H2, H3, H6, H10 RESULTS OF INVESTIGATION: THE VYAIRE SERVICE DEPT. FORWARDED THE SUSPECT COMPONENT TO THE VYAIRE FAILURE ANALYSIS LAB (FA LAB) WHO PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED DURING TESTING. THE O-RINGS WERE DID NOT HAVE AN ADEQUATE AMOUNT OF LUBRICATION. AS ONLY THE POPPET WAS RECEIVED IT IS UNKNOWN WHETHER THE POPPET SLEEVE ALSO HAD INADEQUATE LUBRICATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT #: (B)(4). THE VYAIRE FACTORY SERVICE DEPT. RECEIVED THE MICROBLENDER FROM THE CUSTOMER FOR REPAIR. THE VYAIRE FACTORY SERVICE DEPT. DUPLICATED THE ISSUE REPORTED BY THE CUSTOMER WHICH WAS ISOLATED TO A COMPONENT FAILURE, SPECIFICALLY THE POPPET. THE POPPET WAS REPLACED AND THE MICROBLENDER WAS TESTED. THE MICROBLENDER PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE MICROBLENDER HAS BEEN RETURNED CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE MICROBLENDER IS ALARMING WHILE THE 2 GASES WERE CONNECTED. THE CUSTOMER ADVISED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135582 BLENDER VENTILATOR, CONTINUOUS, FACILITY USE BZR VYAIRE MEDICAL 03803T 10846446002256

    Patients

    Seq Age Sex Outcome Treatment
    1