BEUDAMED
    FDA Adverse Event Death Summary report: N

    V200 VENTILATOR

    MDR report key: 6939340 · Received October 10, 2017

    Report

    Report Number
    2031642-2017-03213
    Event Type
    Death
    Date Received
    October 10, 2017
    Date of Event
    September 30, 2017
    Report Date
    October 3, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP IT WAS REPORTED THAT THE VENTILATOR WAS BEING USED ON AN (B)(6) YEAR OLD MALE WITH NUMEROUS CHRONIC HEALTH ISSUES. THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT TO TREAT AN ANAPHYLACTIC REACTION. AFTER UNSUCCESSFUL INTUBATION ATTEMPTS DUE TO AN ENLARGED TONGUE, AN EMERGENCY CRICOIDECTOMY WAS PERFORMED. THE PATIENT WAS PLACED ON THE V200 VENTILATOR FOR APPROXIMATELY TWO HOURS WHEN A TRANSPORT TEAM ARRIVED TO TAKE HIM TO A LARGER HOSPITAL. THE PATIENT¿S PROPOFOL AND FENTANYL INFUSION WERE TRANSFERRED OVER TO THE TRANSPORT PUMPS AND ALSO THE PATIENT MONITORING WAS MOVED OVER TO THE TRANSPORT MONITOR. THE TRANSPORT TEAM DECIDED TO SUCTION HIS TRACH AS A HIP ALARM HAD SOUNDED USING AN INLINE SUCTION FOR SCANT AMOUNT OF BLOOD. THE VENTILATOR WAS ALARMING AT THIS TIME. A FEW MINUTES LATER THE PATIENT DECOMPENSATED AS THEY NOTED HE WAS ASHEN IN COLOR, HEART RATE OF 34, NO PULSE COULD BE DETECTED AND CPR WAS STARTED. THE NURSE AND THE PHYSICIAN CONFIRMED THE PATIENT¿S DNR STATUS AND RESUSCITATION STOPPED. THE CUSTOMER REPORTED THAT THE VENTILATOR SHOWED A TIDAL VOLUME OF 500ML THAT DECREASED TO 15ML AND DID NOT ALARM. THE PATIENT WAS NEVER REMOVED FROM THE VENTILATOR. THEY WERE NOT SURE IF THERE WAS A BLOCKAGE, LEAK OR DISCONNECT IN THE TUBING AND THEY WERE ALSO CONSIDERING IF A CAP HAD BEEN LEFT OFF DURING SUCTIONING. THIS CHANGE OCCURRED RIGHT AFTER THE RESUSCITATION. THEY WERE ALSO CONSIDERING THAT BECAUSE THE TRACHEOSTOMY HAD JUST BEEN SITED, THE SUCTIONING MIGHT HAVE PUNCTURED THROUGH THE TRACHEA. THE FAMILY REFUSED AUTOPSY. A FIELD SERVICE ENGINEER WHO PERFORMED PREVENTATIVE MAINTENANCE (PM) ON THE MACHINE AND FOUND NO ISSUES. THE DEVICE PASSED ALL THE PM TESTS AND NOTHING WRONG WITH THE DEVICE AND IS READY FOR PATIENT USE. REVIEW OF THE VENTILATION CHART ALSO SHOWS THAT THE PEAK INSPIRATORY PRESSURE (PIP) DECREASED FROM 38 TO 20 CONCURRENT WITH THE DECREASE IN TIDAL VOLUME. INTEGRITY OF THE TUBING CIRCUIT CANNOT BE RULED OUT. IN ADDITION, COMMUNICATION WITH THE CUSTOMER INCLUDED ONLY VISUAL ALARMS AND NO AUDITORY ALARMS ARE POSSIBLE WHEN THE ALARM HAS BEEN SILENCED FOR THE TWO MINUTES.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPN COMPLETION OF THE INVESTIGATION. THE VENTILATOR HAS BEEN SEQUESTERED AND THERE IS A REQUEST FOR A PHILIPS¿ FIELD SERVICE ENGINEER TO INSPECT THE VENTILATOR. ADDITIONAL PATIENT INFORMATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CLINICAL NOTES PROVIDED BY THE CUSTOMER SHOWS THAT THE TIDAL VOLUME DROPPED FROM 500ML TO LESS THAN 20ML. DISCONNECTION OF PATIENT CIRCUIT WAS RULED OUT BECAUSE THE RECORD ALSO SHOWS AN INCREASE IN PIP. THIS IS WITHIN THE TIMEFRAME THAT THE CUSTOMER STATED THE PATIENT REQUIRED RESUSCITATION AND REPORTED THAT THE PATIENT WAS NOT REMOVED FROM THE VENTILATOR. THE VENTILATOR WOULD NOT BE ABLE TO OVERCOME THE INTRA-THORACIC PRESSURE GENERATED FROM THE CHEST COMPRESSIONS AND WOULD THEREFORE REACH A SET HIGH PEAK INSPIRATORY PRESSURE AND STOP DELIVERING THE BREATH AND THAT WOULD BE SEEN IN THE TIDAL VOLUME. THE PATIENT REQUIRED AN EMERGENCY TRACHEOSTOMY AND THIS IS A PROBABLE ROOT CAUSE TO THE PATIENT EVENTS THAT OCCURRED WHILE ON THE VENTILATOR. IN ADDITION, THE ALARM SILENCE WAS REVIEWED WITH THE CUSTOMER AS THEY REPORTED NO ALARM OCCURRED. A VISUAL ALARM WILL BE PRESENT WHEN THE CLINICIAN HAS SILENCED THE AUDITORY ALARM FOR TWO MINUTES. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE VENTILATOR WAS NOT WORKING CORRECTLY AND DID NOT ALARM. THE PATIENT WAS BEING VENTILATED ON A V200 THROUGH A TRACHEOSTOMY. THE CLINICIANS REMOVED THE TUBING TO CLEAN HIS STOMA AND WHEN REINSERTING THE TUBING THE PATIENT EXPIRED. THE PATIENT HAD A DO NOT RESUSCITATE. FURTHER DATA HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718831 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death