BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11952598 · Received June 7, 2021

    Report

    Report Number
    2031642-2021-03988
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 12, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED UPON THE INFORMATION PROVIDED AND ANALYSIS OF THE DEVICE DIAGNOSTIC REPORT, THE THERAPEUTIC MODALITY AT THE TIME OF THE EVENT IN QUESTION WAS FOUND TO BE HIGH FLOW THERAPY (FLOW SETTING 50 L/MIN, FIO2 OF 100%). DURING HIGH FLOW THERAPY THE PATIENT DISCONNECTION ALARM IS DISABLED DUE TO THE OPEN-TO-ATMOSPHERE HIGH FLOW THERAPY INTERFACE REQUIRED FOR TREATMENT. NO FAILURE OR MALFUNCTION OF THE DEVICE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS HAS BEEN NOTED. FURTHERMORE, WARNINGS LOCATED WITHIN THE V60 USER MANUAL STATE: WARNING: PATIENT ALARMS ARE NOT AVAILABLE DURING HIGH FLOW THERAPY (HFT) AS THE THERAPY USES AN OPEN SYSTEM. A NASAL CANNULA OCCUPIES ONLY A PORTION OF THE NARES AND PATIENTS CAN BREATHE THROUGH THEIR MOUTH, WHICH PREVENTS ESTIMATION OF PATIENT PARAMETERS SUCH AS TIDAL VOLUME, RESPIRATORY RATE, PRESSURE, AND MINUTE VENTILATION. PROVIDE EXTERNAL MONITORING, INCLUDING OXIMETRY, TO INFORM THE CLINICIAN OF A CHANGE IN THE PATIENT'S CONDITION. THIS WARNING IS ALSO REFLECTED UPON THE DEVICE GRAPHIC USER INTERFACE WHEN HIGH FLOW THERAPY IS INITIATED, PROVIDING A VISUAL REMINDER OF THE ABSENCE OF PATIENT MONITORING ALARMS DURING THERAPY.

    Additional Manufacturer Narrative · 1

    REPORT DATE: 07JUN2021.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT A PATIENT BECAME DISCONNECTED FROM THE RESPIRONICS V60 VENTILATOR WHILE RECEIVING VENTILATION THERAPY, AND THE DEVICE DID NOT GENERATE A DISCONNECT ALARM. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF REPORTED DEVICE BEHAVIOR AND ADVERSE EVENT. 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 VENTILATION THERAPY VIA THE RESPIRONICS V60 VENTILATOR WITH SOFTWARE VERSION (B)(4); PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, PATIENT CIRCUIT, AND PATIENT INTERFACE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING THERAPY VIA THE V60 DEVICE, WHEN THE PATIENT BECAME DISCONNECTED FROM THE DEVICE; LOCATION NOT REPORTED, THE DEVICE DID NOT GENERATE A DISCONNECT ALARM, AND THE PATIENT EXPERIENCED AN EVENT OF A DECREASE IN PERIPHERAL OXYGEN CAPILLARY SATURATION (SPO2) BELOW 80%. A PHILIPS AUTHORIZED REPRESENTATIVE EVALUATED THE DEVICE AND WAS UNABLE TO CONFIRM THE SYMPTOM. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF REPORTED DEVICE BEHAVIOR AND ADVERSE EVENT. REVIEW OF THE PROVIDED DIAGNOSTIC (DRPT) REPORT SHOWED THE DEVICE GENERATED A PROXIMAL PRESSURE LINE DISCONNECT (1202) ALARM. NO CONTINUOUS BUILT-IN TESTS OR POWER ON SELF-TEST ERROR CODES WERE GENERATED. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842864 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other