BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1191875 · Received October 1, 2008

    Report

    Report Number
    2031642-2008-00205
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-2002-04-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WOULD NOT POWER ON AND MAINS POWER LED WAS NOT LIT. THE VENTILATOR WAS NOT IN USE ON A PT AND THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. THE INTL DISTRIBUTOR INSPECTED THE VENTILATOR AND REPORTED THE SNUBBER BOARD ON THE VENTILATOR POWER SUPPLY HAD SIGNS OF DAMAGE DUE TO OVERHEATING. THE DISTRIBUTOR REPLACED THE POWER SUPPLY TO CORRECT THE PROBLEM. UPON COMPLETION OF SERVICE, THE UNIT PERFORMED PER OPERATING SPECS. DAMAGE TO THE SNUBBER PCB AND POWER SUPPLY MAY RESULT IN A MALFUNCTION OF THE POWER SUPPLY. MALFUNCTION OF THE POWER SUPPLY DURING USE COULD CAUSE THE VENTILATOR TO SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA