BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1964072 · Received January 19, 2011

    Report

    Report Number
    2031642-2011-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PARTS NOT RETURNED DUE TO CUSTOMS. PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED AN INHALATION AUTOZERO TEST FAILURE DURING POWER ON SELF TEST. THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE ,WAS NO PATIENT INVOLVEMENT OR HARM. AN AUTOZEROING FAILURE MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT, THEREFORE, THIS EVENT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF AN AUTOZEROING FAILURE WERE TO RECUR WHILE IN USE ON A PATIENT. THE CUSTOMER REPLACED THE SENSOR PCB BOARD TO CORRECT THE FINDING.

    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