BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1030668 · Received April 15, 2008

    Report

    Report Number
    2031642-2008-00087
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    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 WENT VENT INOP AND ALARMED WHILE IN USE ON A PT. THE CUSTOMER REPORTED THERE WAS NO PT HARM. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PT. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. AFTER OPERATING THE VENTILATOR IN NORMAL MODE FOR A FEW MINUTES, THE UNIT WENT VENT INOP DUE TO AN INHALATION AUTOZERO FAILURE. UPON INSPECTION OF THE VENTILATOR, THE SERVICE TECHNICIAN REPORTED FINDING THE INHALATION PRESSURE TRANSDUCER HOSE WAS PINCHED BETWEEN THE TOP AND BOTTOM ENCLOSURES. THE CUSTOMER HAD RECENTLY COMPLETED PERFORMING A 12.5K PREVENTIVE MAINTENANCE SERVICE ON THE VENTILATOR AND PINCHED THE HOSE UPON REASSEMBLING THE VENTILATOR FOR USE. THE MANUFACTURER'S SERVICE TECHNICIAN REPOSITIONED THE TRANSDUCER HOSE TO CORRECT THE PROBLEM CAUSED AS A RESULT OF THE CUSTOMER'S SERVICE.

    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