BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1286177 · Received January 13, 2009

    Report

    Report Number
    2031642-2009-00003
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    December 14, 2008
    Report Date
    December 15, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION FROM THE CHARGE NURSE, IT IS BELIEVED THAT FOLLOWING THE INTERVENTIONS REQUIRED TO STABILIZE THE PATIENT FOR THE ARREST SITUATION, THE VENTILATOR ALARMS BEGAN. THE REQUIRED INTERVENTIONS RESULTED IN A CHANGE IN THE LUNG MECHANICS OF THE PATIENT. THERE WERE CHANGES IN PATIENT POSITIONING FOR REPORTED INSERTION OF THE TRANSESOPHAGEAL PROBE DURING THE ARREST, AND THE PROCESS OF THE CARDIOVERSION ITSELF. PER THE TRENDING INFORMATION REVIEWED ON THE VENTILATOR, THE VENTILATION MODE WAS VCV AND THERE WAS AN INCREASE IN AIRWAY PRESSURE, WHICH REACHED THE HIGH INSPIRATORY PRESSURE (HIP) ALARM LIMIT. AT THAT OCCURRENCE, THE VENTILATOR WOULD TRUNCATE THE BREATH, RESULTING IN THE OBSERVED REDUCTION OF TIDAL VOLUME DELIVERY. THE NURSES AND ANAESTHETISTS FAILED TO RECOGNIZE AND RESPOND TO WHAT WAS HAPPENING WITH THE VENTILATOR AND THEREBY TO THE PATIENT. THE HIP ALARM LIMIT REQUIRED ADJUSTMENT TO THE CHANGED CONDITION OF THE PATIENT, OR A CONSIDERATION OF CHANGE TO PRESSURE CONTROLLED VENTILATION SOONER. CUSTOMER TRAINING IS TO INCLUDE KNOWLEDGE AND RESPONSE FOR VENTILATOR ALARM CONDITIONS.

    Description of Event or Problem · 1

    THE SENIOR CHARGE NURSE REPORTED WHILE THE VENTILATOR WAS IN USE ON THE PATIENT POST-OPERATIVELY, THE PATIENT HAD AN EPISODE OF ACUTE HYPERTENSION FOLLOWED BY A PERI-ARREST SITUATION. AS DESCRIBED THERE WAS A PERIOD OF HYPERTENSION FOLLOWED BY HYPOTENSION AND THEN EPISODE OF VENTRICULAR TACHYCARDIA. THE PATIENT NEEDED CARDIOVERSION TO RESTORE SINUS RHYTHM. THEY REPORTED THAT THE PATIENT WASN¿T VENTILATING ADEQUATELY WHEN THE VENTILATOR WAS ALARMING FOR HIGH INSPIRATORY PRESSURE (HIP) AND LOW TIDAL VOLUME. THEY REPORTED IT APPEARED THERE WAS MINIMAL CHEST WALL MOVEMENT. THEY REMOVED THE PATIENT FROM THE VENTILATOR AND MANUALLY BAGGED THE PATIENT AT 100% OXYGEN. THE PATIENT WAS SUCTIONED FOR A MODERATE AMOUNT OF SECRETIONS. THE PATIENT WAS PLACED BACK ON THE VENTILATOR BUT REPORTED THE VENTILATOR AGAIN WAS ALARMING FOR HIP AND LOW TIDAL VOLUMES. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR USING PRESSURE CONTROL VENTILATION WITH ADEQUATE VENTILATION REPORTED. THE ALARM REPORTED BY THE CUSTOMER WAS THE HIGH INSPIRATORY PRESSURE ALARM, WHICH WAS SET AT 35CMH2O. THE PATIENT DATA INDICATED THAT THE READINGS HAD JUMPED TO 35.1CMH2O, CAUSING THE ALARM TO ACTIVATE. WHEN THE HIP ALARM LIMIT IS REACHED DURING A BREATH, THE VENTILATOR IMMEDIATELY CYCLES INTO THE EXHALATION PHASE AND ACTIVATES VISUAL AND AUDIBLE ALARMS. THIS ALARM WOULD NORMALLY BE ADDRESSED BY ANY NURSING STAFF IN ATTENDANCE. WHEN THE VENTILATOR CYCLES INTO THE EXHALATION PHASE, THE BREATH TIDAL VOLUME BEING DELIVERED TO THE PATIENT IS TRUNCATED, THEREFORE THE TIDAL VOLUME DELIVERED TO THE PATIENT MAY BE INAPPROPRIATE. THE DATA LOG IN THE VENTILATOR FOUND CODES CONSISTENT WITH THE DEVICE BEING SWITCHED ON, AND NORMAL DEVICE OPERATION. NO CODES WERE OBSERVED THAT WOULD INDICATE A DEVICE FAILURE.

    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 Required Intervention