BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1111890 · Received August 12, 2008

    Report

    Report Number
    2031642-2008-00181
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 14, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RISK MANAGEMENT WAS INFORMED OF THE REPORTED HME INLINE, AND THAT THE HOSPITAL STAFF MUST BE AWARE OF SETTING VENTILATOR ALARMS APPROPRIATELY FOR EACH PATIENT, AND THAT THE LIP ALARM SHOULD BE TESTED WHEN THE VENTILATOR IS USED ON A PATIENT, ESPECIALLY WITH OTHER DEVICES PLACED INLINE IN THE PATIENT CIRCUIT. IT WAS EXPLAINED THAT IF THE LIP ALARM WASN'T SET PROPERLY, AND THE HME OR SOME OTHER OBSTRUCTION SUCH AS THE PATIENT OR BEDDING, ETC. WAS GOOD TO INCREASE THE GAS FLOW RESISTANCE AND KEEP THE VENTILATOR PRESSURE ABOVE THE LIP SETTING THAT THE LIP ALARM WOULD NOT ACTIVATE.

    Description of Event or Problem · 1

    THE RESPIRATORY THERAPY (RT) TEAM LEADER REPORTED THE PATIENT WAS IN THE ER ON A MONITOR. THE MONITORING INDICATED THE PATIENT'S OXYGEN SATURATION WAS DECREASING. IT WAS UNKNOWN WHAT LEVEL THE OXYGEN SATURATION DECREASED TO. NURSING RESPONDED TO THE PATIENT AND REPORTED THE PATIENT WAS DISCONNECTED FROM THE PATIENT CIRCUIT, AND THERE WAS NO ALARM EMITTED FROM THE VENTILATOR. HOSPITAL RISK MANAGEMENT REPORTED THE HOSPITAL INCIDENT REPORT INDICATED BOTH NURSE AND MD RESPONDED TO THE PATIENT AND THERE WAS NO VENTILATOR ALARM DURING DISCONNECT. THE PATIENT WAS BAGGED WHICH BROUGHT THE OXYGEN SATURATION BACK UP TO 100% AND PUT THE PATIENT ON ANOTHER VENTILATOR. AN HME WAS BEING USED INLINE WITH THE PATIENT CIRCUIT. THE VENTILATOR SETTING FOR THE LOW INSPIRATORY PRESSURE (LIP) ALARM WAS UNKNOWN. THE PATIENT SUFFERED NO PERMANENT HARM OR IMPAIRMENT. MANUFACTURER'S SERVICE TECHNICIAN PERFORMED EVALUATION AND TESTING OF UNIT. DURING EVALUATION AND TESTING THE VENTILATOR FUNCTIONED TO SPECIFICATIONS, INCLUDING ALARMS.

    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 Required Intervention HME