BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1083354 · Received July 28, 2008

    Report

    Report Number
    2031642-2008-00179
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR PERFORMED A SNUBBER BOARD REPLACEMENT IN THE VENTILATOR PER FIELD ACTION NOTIFICATION. THE DISTRIBUTOR RETURNED THE SNUBBER BOARD TO THE MFR. THERE WAS NO PROBLEM REPORTED WITH THE VENTILATOR PRIOR TO FIELD ACTION SERVICE. THE VENTILATOR WAS NOT IN USE ON THE PT AND THEREFORE THERE WAS NO PT INVOLVEMENT OR HARM. UPON RECEIPT OF THE SNUBBER BOARD AT THE MFR, VISUAL EXAMINATION REVEALED SIGNS OF DAMAGE TO THE SNUBBER PCB AS A RESULT OF ARCING. DAMAGE TO THE SNUBBER PCB 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