BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11667464 · Received April 14, 2021

    Report

    Report Number
    2031642-2021-03371
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 15, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985. B4:14JUL2021. THE CUSTOMERS ALLEGED MALFUNCTION WAS CONFIRMED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS A FAULTY FLOW SENSOR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING HIGH FLOW THERAPY TO A PATIENT, THE RESPIRONICS V60 VENTILATOR STOPPED WORKING AND HAD NO FLOW. A PHILIPS AUTHORIZED REPRESENTATIVE EVALUATED THE DEVICE. THE REPORTED ISSUE WAS CONFIRMED AND TRACED TO A FAULTY FLOW SENSOR. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND ADVERSE EVENT. THE PHILIPS AUTHORIZED REPRESENTATIVE REPLACED THE FLOW SENSOR. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS AND WAS RETURNED TO THE CUSTOMER. THIS REPORTER STATED THAT A (B)(6) YEARS OLD MALE PATIENT WITH A DATE OF BIRTH OF (B)(6), A WEIGHT OF (B)(6) KILOGRAMS, AND AN UNKNOWN HEIGHT, 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 VIA THE RESPIRONICS V60 VENTILATOR WITH SOFTWARE VERSION 3.0, A FLOW RATE OF 40 LITERS PER MINUTE, FRACTION OF INSPIRED OXYGEN (FIO2) AT 60%, PATIENT CIRCUIT FISHER & PAYKEL RT 232, FISHER & PAYKEL MR 850 HUMIDIFIER WITH A TEMPERATURE OF 31 DEGREES CELSIUS, INLINE FEP (WITH OR WITHOUT FILTER) OR DEP P100 VIRAL FILTER, AND A FISHER & PAYKEL OPTIFLOW OPT944 HIGH FLOW NASAL CANNULA; SIZE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING HIGH FLOW THERAPY VIA THE V60 DEVICE, WHEN THE DEVICE STOPPED WORKING IN HIGH FLOW THERAPY MODE AND NO FLOW WAS PROVIDED TO THE PATIENT, THE PATIENT EXPERIENCED AN EVENT OF LOW PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2); VALUES NOT REPORTED, HOSPITAL STAFF INITIATED A RAPID RESPONSE, THE PATIENT WAS ADMINISTERED MANUAL VENTILATION WITH OXYGEN VIA A BAG VALVE MASK; FLOW RATE NOT REPORTED, THE PATIENT WAS PLACED ON ANOTHER VENTILATOR; BRAND, MODEL, AND PRESCRIPTION NOT REPORTED, THERAPY WAS CONTINUED, AND THE EVENT OF LOW SPO2 RESOLVED. NO DEVICE ALARMS WERE REPORTED. NO RELEVANT LABORATORY DATA WAS REPORTED. REVIEW OF THE PROVIDED DIAGNOSTIC REPORT FROM THE REPORTED DATE OF EVENT SHOWED THE DEVICE GENERATED AN OXYGEN NOT AVAILABLE AND A LOW OXYGEN SUPPLY PRESSURE ALARM. THIS WAS A MALFUNCTION OF THE FLOW SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562541 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention