BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPIRIT VENTILATOR

    MDR report key: 1060144 · Received June 11, 2008

    Report

    Report Number
    2031642-2008-00142
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR RESTARTED AND ALARMED WHILE IN USE OF A PT. THE CUSTOMER REPORTED THERE WAS NO PT HARM. DURING EVAL OF THE UNIT, THE MFR'S SVC TECH REPORTED WHEN THE OPTICAL ROTARY ENCODER CABLE WAS TOUCHED, THE VENTILATOR RESTARTED. THE SVC TECH WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE SVC TECH REPORTED THE ENCODER HAD A WORN SPOT WITH A WIRE VISIBLE. THE SVC TECH REPLACED THE OPTICAL ROTARY ENCODER TO COMPLETE THE REPAIR. EXTENDED SELF TESTING (EST) WAS COMPLETED AND ALL TESTS PASSED TO OPERATING SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPIRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK