BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS REMSTAR PRO

    MDR report key: 14206327 · Received April 25, 2022

    Report

    Report Number
    MW5109345
    Event Type
    Death
    Date Received
    April 25, 2022
    Report Date
    April 22, 2022
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY MOTHER EXPERIENCED PERIODIC RESPIRATORY DISTRESS THAT PROGRESSED INTO SEVERE RESPIRATORY ISSUES. SHE EXPERIENCED INFLAMMATION OF HER AIRWAY THAT PRESENTED LIKE A REACTIVE AIRWAY. SHE WENT INTO CARDIAC ARREST FROM HYPOXEMIA AND SUBSEQUENTLY WAS VENTILATOR DEPENDENT WITH LOSS OF COGNITIVE FUNCTION. SHE WAS REMOVED FROM THE VENTILATOR AND ALLOWED TO PASS AWAY. FDA SAFETY REPORT ID #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970873 PHILIPS REMSTAR PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. 460P

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death| H