BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1060147 · Received June 11, 2008

    Report

    Report Number
    2031642-2008-00129
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    FDA NOTIFIED 02/08/2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    INFO WAS REC'D FROM AN INTL CUSTOMER THAT THE SNUBBER BOARD ON THE VENTILATOR POWER SUPPLY HAD SIGNS OF DAMAGE DUE TO OVERHEATING. THE VENTILATOR WAS NOT IN USE ON A PT, THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. THE MFR'S SVC TECH REPLACED THE POWER SUPPLY TO CORRECT THE FINDINGS. 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 VENTILTOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA