BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATIONAUTOCPAPHUMCELL DOM

    MDR report key: 12883173 · Received November 26, 2021

    Report

    Report Number
    MW5105622
    Event Type
    Injury
    Date Received
    November 26, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 23, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    006069590205639
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NOTIFIED TO STOP USING CPAP BY PHILIPS DUE TO AGE OF MACHINE REF DSX500H11C. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777224 DREAMSTATIONAUTOCPAPHUMCELL DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX500H11C 006069590205639

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| L ATORVASTATIN | LOSARTAN | MULTI-VITAMIN | NOVOLOG| VITAMIN D