BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1023649 · Received April 1, 2008

    Report

    Report Number
    2031642-2008-00079
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN INTERNATIONAL DISTRIBUTOR THAT THE VENTILATOR EXHIBITED AN ODOR OF OVERHEATING. THE VENTILATOR WAS NOT IN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE DISTRIBUTOR'S SERVICE TECHNICIAN CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED THE SNUBBER BOARD ON THE POWER SUPPLY WAS DAMAGED DUE TO OVERHEATING. THE SERVICE ENGINEER REPLACED THE POWER SUPPLY TO CORRECT THE FINDINGS. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED PER OPERATING SPECIFICATIONS. DAMAGE DUE TO OVERHEATING OF 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