BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM ONE RESPIRATOR

    MDR report key: 7302441 · Received February 27, 2018

    Report

    Report Number
    MW5075570
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    October 1, 2017
    Report Date
    February 23, 2018
    Manufacturer
    PHILLS / RESPIRONICS, INC.
    Product Code
    BZK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FELL TWICE, JUST DROPPED WITHOUT ANY INDICATIONS. HAVING DIZZY SPELLS. FEELING PRESSURE BETWEEN MY EARS (HEAD) WENT TO DR, SAID HAD DEFECT IN MY LEFT INNER EAR. PRESCRIBED PHYSICAL THERAPY, FOUR SESSIONS, NO HELP. FELT BETTER FOR A WHILE. POSSIBLE SIDE EFFECTS FROM COMBINATION OF BREATHING MACHINE, AMLODIPINE BESYLATE 5 MG, LOSARTAN 100-25MG AUR, METFORMIN HCL DR 500 MG TABS, INSULIN HUMALOG AND BASAGLAR. AN (B)(6) MALE. DATES OF USE: 2 YEARS. DIAGNOSIS OR REASON FOR USE: SLEEP. "EVENT ABATED AFTER USE STOPPED: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144488 SYSTEM ONE RESPIRATOR SYSTEM ONE RESPIRATOR BZK PHILLS / RESPIRONICS, INC. SYSTEM ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability