BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2010362 · Received March 8, 2011

    Report

    Report Number
    2031642-2011-00060
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 14, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR RESTARTED AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT DURING TESTING OF THE UNIT. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG HISTORY INDICATED THE OCCURRENCE OF A RESTART OF THE VENTILATOR. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDING. EXTENDED SELF TESTING AND APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    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