BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1070513 · Received July 7, 2008

    Report

    Report Number
    2031642-2008-00153
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED AND RESTARTED WHILE IN USE ON A PT. THE CUSTOMER REPORTED THERE WAS NO PT HARM. THE HOSPITAL BIOMEDICAL TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A +24 VOLT FAILURE. THE BIOMEDICAL TECHNICIAN REPLACED THE POWER SUPPLY AS PER THE SERVICE MANUAL TO ADDRESS THE CODE IN THE DIAGNOSTIC LOG.

    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