BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAS Z1

    MDR report key: 15231228 · Received August 16, 2022

    Report

    Report Number
    9617566-2022-00007
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    June 2, 2022
    Report Date
    August 16, 2022
    Manufacturer
    BREAS MEDICAL INC.
    Product Code
    BZD
    PMA / PMN Number
    K140929
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER CUSTOMER COMPLAINT #(B)(4) THE FOLLOWING WAS ALLEGED: "ON (B)(6) 2022 THE PATIENT BOUGHT THE DEVICE AT LÖWENSTEIN CENTER DORTMUND TO BE PREPARED FOR A FOLLOWING HOLIDAY. INSTANTLY AFTER THE USAGE DURING HER HOLIDAY IT TURNED OUT THAT THE DEVICE DOES NOT FULFILL THE EXPECTED REQUIREMENTS. DURING THIS HOLIDAY SHE SUFFERED FROM A SLIGHT STROKE. THE MEDICATED DOCTORS ARE SURE THAT THIS DEVICE IS MAINLY THE REASON FOR THIS OCCURRENCE." NOTE: THE EVENT IS UNCONFIRMED AT THIS POINT AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE INITIAL REPORTER

    Description of Event or Problem · 0

    PER CUSTOMER COMPLAINT #(B)(4) THE FOLLOWING WAS ALLEGED: "ON (B)(6) 2022 THE PATIENT BOUGHT THE DEVICE AT (B)(6) TO BE PREPARED FOR A FOLLOWING HOLIDAY. INSTANTLY AFTER THE USAGE DURING HER HOLIDAY IT TURNED OUT THAT THE DEVICE DOES NOT FULFILL THE EXPECTED REQUIREMENTS. DURING THIS HOLIDAY SHE SUFFERED FROM A SLIGHT STROKE. THE MEDICATED DOCTORS ARE SURE THAT THIS DEVICE IS MAINLY THE REASON FOR THIS OCCURRENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011833 BREAS Z1 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BREAS MEDICAL INC. BREAS Z1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other