BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP PHILLIPS RESPIRONICS SYSTEM ONE HTD HUMID

    MDR report key: 12280726 · Received August 4, 2021

    Report

    Report Number
    MW5103018
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    January 17, 2021
    Report Date
    August 3, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    MNS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOUND BLACK FOAM PARTICULATES IN THE WATER TANK OF THE CPAP - RESPIRONICS REMSTAR PLUS, DOM S/N (B)(4); SYSTEM ONE HTD HUMID, DOM S/N (B)(4). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169482 CPAP PHILLIPS RESPIRONICS SYSTEM ONE HTD HUMID VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILIPS / RESPIRONICS, INC. SYSTEM ONE
    1169483 RESPIRONICS REMSTAR PLUS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| S