BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4898987 · Received July 8, 2015

    Report

    Report Number
    2031642-2015-01215
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    May 14, 2015
    Report Date
    June 11, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE SHUT DOWN WHILE IN USE. THE CUSTOMER REPORTED THE PATIENTS OXYGEN SATURATION DROPPING WHEN THE POWER LOSS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442611 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention