BEUDAMED
    FDA Adverse Event Summary report: N

    REMSTAR PLUS M W/ HUMIDIFIER

    MDR report key: 1032564 · Received March 25, 2008

    Report

    Report Number
    1032564
    Date Received
    March 25, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE CPAP DEVICE STOPPED WORKING IN THE MIDDLE OF THE NIGHT. PATIENT REPORTED AWAKENING "FEELING LIKE I AM BEING SUFFOCATED". THE PATIENT DISCONTINUED USE OF DEVICE. THE DEVICE WAS CHECKED TO ENSURE THAT DEVICE HAD BEEN SET UP PROPERLY. WHEN HOSPITAL STAFF CALLED THE VENDOR, THEY REPORTED THAT HUMIDIFIER HAS BEEN DISCONTINUED FROM USE. BOTH FLOW GENERATOR (CPAP DEVICE) AND HUMIDIFIER ARE BEING RETURNED TO MANUFACTURER. MANUFACTURER IS REPLACING BOTH UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR PLUS M W/ HUMIDIFIER VENTILATOR, CPAP BZD RESPIRONICS, INC. DS200H *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR