BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 12140766 · Received July 9, 2021

    Report

    Report Number
    2031642-2021-04285
    Event Type
    Death
    Date Received
    July 9, 2021
    Date of Event
    June 28, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B4:(B)(6)2021. REVIEW OF THE PROVIDED PICTURES OF THE DIAGNOSTIC REPORT (DRPT) FROM (B)(6) 2021, SHOWED THAT THE DEVICE WAS IN HIGH FLOW THERAPY MODE, AND THERE WERE MULTIPLE CANNOT REACH TARGET FLOW (122D) AS WELL AS OXYGEN NOT AVAILABLE (1208) ALARMS GENERATED. ALSO, THERE WERE MULTIPLE RUNNING ON INTERNAL BATTERY (1212) AND AC POWER RESTORED (2005) ALARMS GENERATED THROUGHOUT THE DRPT. THERE WAS NO SYSTEM SHUTDOWN (2002) ALARMS GENERATED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY AN INTERNATIONAL PHILIPS FIELD SERVICE ENGINEER (FSE). FULL PERFORMANCE VERIFICATION TESTING WAS CONDUCTED ON THE UNIT IN QUESTION WITH NO FAULT OR FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS FOUND. THE DEVICE HAS SINCE BEEN RELEASED BACK TO THE INSTITUTION WITH NO RESTRICTIONS ON USE BY THE PHILIPS FSE. BASED UPON THE INFORMATION PROVIDED, NO MALFUNCTION, FAULT, OR FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS FOUND. AS PER THE V60 VENTILATOR USER GUIDE: VENTILATOR CODE 122D (CANNOT REACH TARGET FLOW) DISPLAYS WHEN HFT (HIGH FLOW THERAPY) IS ACTIVE AND INDICATES THAT FLOW TARGET IS NOT ACHIEVED. THE DEVICE WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT. CORRECTIVE ACTIONS ARE TO CHECK THE PATIENT. CHECK THAT THE NASAL CANNULA SIZE IS APPROPRIATE FOR THE FLOW SETTING. CHECK THAT AN OCCLUSIVE INTERFACE IS NOT IN USE (A CANNULA FULLY SEALED WITHIN THE NARES, AN NIV MASK OR DIRECT CONNECTION TO AN ETT/TRACH). CHECK FOR AN OCCLUSION, KINK OR LIQUID IN THE PATIENT CIRCUIT. VENTILATOR CODE 1208 (OXYGEN NOT AVAILABLE) DISPLAYS WHEN THE OXYGEN SUPPLY PRESSURE OUT OF RANGE, OXYGEN DEVICE FAILED, AIR FLOW SENSOR AND/ OR OXYGEN FLOW SENSOR CALIBRATION FAILED, OR OXYGEN INLET PRESSURE SENSOR CALIBRATION FAILED. THE VENTILATOR DISCONTINUES OXYGEN SUPPORT. CORRECTIVE ACTIONS ARE TO CHECK THE PATIENT. CHECK IF HIGH/LOW O2 SOURCE IS THE PROBLEM AND CORRECT. IF PROBLEM PERSISTS, PROVIDE ALTERNATIVE VENTILATION. HAVE VENTILATOR SERVICED. BASED UPON THE INFORMATION PROVIDED, CLINICAL ANALYSIS AND REVIEW BY PHILIPS RESPIRONICS HRC MEDICAL DIRECTOR HAS DETERMINED THE DESIGN OF THE CRTF ALARM LIKELY CONTRIBUTED TO SEVERE HYPOXEMIA AS EVIDENCED BY THE DEVICE RECORDED EVENT LOG. THERE WERE MANY ADJUSTMENTS TO FLOW AND FIO2 AS WELL AS MULTIPLE OCCASIONS OF REQUIRING 100% FIO2, AN INTERVENTION THAT WOULD NOT HAVE BEEN PERFORMED UNLESS THE PATIENT WAS EXHIBITING A CHANGE IN CLINICAL CONDITION. HOWEVER, IT IS NOT FELT THAT THE DESIGN OF THE CRTF ALARM CAUSED THE PATIENT¿S DEATH. THE DEATH WAS LIKELY CAUSED BY THE FOLLOWING: A PERSISTENTLY POOR CLINICAL CONDITION, AN INAPPROPRIATENESS OF THIS PATIENT BEING MAINTAINED ON THIS DEVICE FOR 36 HOURS GIVEN THE VAST NUMBER OF ALARMS, COMBINED WITH WHAT APPEARS TO BE A LACK OF APPROPRIATE AND TIMELY INTERVENTION OR ESCALATION TO ANOTHER FORM OF THERAPY. FURTHER, THERE IS A POSSIBILITY BASED ON THE PHOTOS INCLUDED WITH THIS COMPLAINT THAT AN INCORRECT CANNULA (AC611 SIZE SMALL) WAS BEING USED (ONLY SPECIFIED FOR FLOWS </ 70 LPM).

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 07/07/2021. CUSTOMER PHONE NUMBER: (B)(6). ADDITIONAL PATIENT OUTCOME: DEATH.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING THERAPY TO A PATIENT, THE RESPIRONICS V60 VENTILATOR POWERED OFF AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND PATIENT OUTCOME. THIS REPORTER STATED THAT A PATIENT OF UNKNOWN AGE, GENDER, HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH THE ADMITTING DIAGNOSIS NOT REPORTED. NO RELEVANT MEDICAL HISTORY, RELEVANT PAST DRUG HISTORY OR RELEVANT CONCOMITANT MEDICAL PRODUCTS WERE REPORTED. WHILE ADMITTED ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED HIGH FLOW THERAPY (HFT) AT 80 LITERS PER MINUTE (L/MIN) VIA THE RESPIRONICS V60 VENTILATOR WITH SOFTWARE VERSION 3.0, FISHER & PAYKEL OPTIFLOW HIGH FLOW NASAL CANNULA LARGE SIZE, FISHER & PAYKEL MR850 RESPIRATORY HUMIDIFIER, AND FISHER & PAYKEL RT319 PATIENT CIRCUIT. THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING HFT VIA THE V60 DEVICE, WHEN HOSPITAL STAFF ATTEMPTED THREE TIMES TO ACHIEVE A FLOW RATE OF 80 L/MIN, AND THREE TIMES THE DEVICE POWERED OFF AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH. NO DEVICE ALARMS WERE REPORTED. NO RELEVANT LABORATORY DATA WAS REPORTED. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043057 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death