BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1060146 · Received June 11, 2008

    Report

    Report Number
    2031642-2008-00138
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 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
    IN
    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 VENTILATOR EXHIBITED AN ODOR OF OVERHEATING WHILE IN USE ON A PT. THE VENTILATOR WAS REMOVED FROM SVC. THE CUSTOMER REPORTED THERE WAS NO PT HARM. THE DISTRIBUTOR'S SVC ENGINEER PERFORMED CHECKOUT OF THE VENTILATOR AND REPORTED THERE WAS NO INDICATION OF AC POWER TO THE UNIT. VISUAL INSPECTION OF THE INTERIOR OF THE VENTILATOR FOUND HEAT RELATED DAMAGE TO THE SNUBBER PCB ON THE POWER SUPPLY. THE SVC ENGINEER REPLACED THE POWER SUPPLY FOR THE NOTED SNUBBER PCB OVERHEATING. DURING REPAIR THE SVC ENGINEER REPORTED THE VENTILATOR DID A RESTART. THE SERVICE ENGINEER REPLACED THE CPU PCB TO CORRECT THAT FINDING. 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 UNK