BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1083586 · Received July 29, 2008

    Report

    Report Number
    2031642-2008-00167
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 12, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    FDA NOTIFIED 2/8/2008
    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 CUSTOMER REPORTED THE VENTILATOR WOULD NOT POWER ON VIA AC POWER. THE VENTILATOR WAS NOT IN USE ON A PT AND THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. THE MFR'S SERVICE TECH CONFIRMED THE UNIT WOULD NOT POWER ON. THE SERVICE TECH REPLACED THE POWER SUPPLY TO CORRECT THE PROBLEM. FINAL TESTING WAS COMPLETED AND THE UNIT PASSED PER OPERATING SPECIFICATIONS. THE POWER SUPPLY WAS RETURNED TO THE MFR FOR FACTORY FAILURE ANALYSIS. VISUAL INSPECTION AND TESTING DURING FAILURE ANALYSIS REVEALED SIGNS OF DAMAGE TO THE SNUBBER PCB ON THE POWER SUPPLY 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