BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11327903 · Received February 15, 2021

    Report

    Report Number
    2031642-2021-00598
    Event Type
    Injury
    Date Received
    February 15, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 5, 2021
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:25FEB2021; B4:01MAR2021; H11:G5:K102985. H10: THERE WAS NO REQUEST FOR A FIELD SERVICE ENGINEER (FSE) ONSITE VISIT AND NO SERVICE ORDER WAS OPENED IN REGARDS TO THIS ALLEGATION. THIS COMPLAINT WAS RECEIVED THROUGH THE CUSTOMER FEEDBACK PROCESS. THERE WAS NO REQUEST FOR TECHNICAL SUPPORT REGARDING THIS ALLEGATION AND THERE IS NO RECORD OF A SERVICE ORDER BEING OPENED. PHILIPS IS UNABLE TO CONFIRM THE CUSTOMER¿S ALLEGATION SINCE THERE WAS NO TECHNICAL SUPPORT REQUESTED. NO DIAGNOSTIC REPORT WAS PROVIDED FOR REVIEW. THE CANNOT REACH TARGET FLOW (122D) IS A LOW PRIORITY ALARM THAT MAY OCCUR DURING HIGH FLOW THERAPY. THE ALARM IS GENERATED WHEN THE MACHINE PRESSURE REACHED ITS MAXIMUM AND COULD NOT ACHIEVE THE TARGET FLOW. THE RECOMMENDED REPAIR IS 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, AND CHECK THE PATIENT CIRCUIT FOR OCCLUSIONS, KINKS, OR LIQUID (RESPIRONICS V60/V60 PLUS VENTILATOR, SERVICE MANUAL, PUBLICATION NUMBER 1049766, REVISION K, PAGE 103). NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTING AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. THIS REPORTER STATED THAT A MALE PATIENT OF UNKNOWN AGE, HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF CORONAVIRUS (COVID 19). 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 NOCTURNAL BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) AND DIURNAL HIGH FLOW THERAPY VIA THE RESPIRONICS V60 VENTILATOR. THE HIGH FLOW THERAPY CONFIGURATION INCLUDED; FISHER & PAYKEL RT219 ADULT BREATHING CIRCUIT BI-LEVEL/CPAP LIMB HEATED, PHILIPS AC611 HIGH FLOW NASAL CANNULA MEDIUM SIZE, FISHER & PAYKEL MR850 HUMIDIFIER, AND FISHER & PAYKEL MR290 CHAMBER. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING BIPAP THERAPY VIA THE V60 DEVICE IN A COVID ISOLATION ROOM, THE HOSPITAL STAFF CHANGED THE THERAPY TO HIGH FLOW THERAPY, THE V60 DID NOT PRODUCE A FLOW, THE DEVICE GENERATED A CANNOT REACH TARGET FLOW (122D) ALARM, THE PATIENT EXPERIENCED AN EVENT OF DECREASED PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) TO THE 70¿S, AND HOSPITAL STAFF ADMINISTERED A NON-REBREATHER MASK OVER THE HIGH FLOW NASAL CANNULA. HOSPITAL STAFF THEN INCREASED THE FLOW RATE TO 80 LITERS PER MINUTE (L/MIN) WITH 100% FRACTION OF INSPIRED OXYGEN (FIO2), THE V60 DID NOT DISPLAY A FLOW GRAPHIC ON THE DEVICE¿S SCREEN AND NOW FLOW WAS HEARD, SO THE PATIENT WAS PLACED BACK ON BIPAP THERAPY FOR RECOVERY. POST RECOVERY, HOSPITAL STAFF THEN CHANGED THE THERAPY BACK TO HIGH FLOW THERAPY; THE FLOW WOULD DROP DOWN TO ZERO AND THEN RAMP UP OVER THREE TO FIVE SECONDS. THE REPORTER STATED THAT THE PATIENT HAD A ¿CLOGGY NOSE¿ AND THAT THE DEVICE IS TOO SENSITIVE TO ANY KIND OF CANNULA MOVEMENT. THE EVENT OF OXYGEN DESATURATION RESOLVED. THERE IS NO INFORMATION TO SUPPORT THAT A MALFUNCTION OCCURRED. THE DEVICE WAS BEHAVING AS INTENDED WHEN IT ALERTED THE USER TO AN OCCLUSIVE CONDITION. THE CANNOT REACH TARGET FLOW ALARM IS AN EXPECTED DEVICE BEHAVIOR WHEN AN OCCLUSION OCCURS IN THE PATIENT CIRCUIT AND THE MACHINE PRESSURE IS OUTSIDE THE RANGE TO DELIVERY THERAPY. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2021. DATE OF REPORT: 15FEB2021.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE RECEIVING HIGH FLOW THERAPY FROM THE RESPIRONICS V60 VENTILATOR, A PATIENT EXPERIENCED AN EVENT OF OXYGEN DESATURATION. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE REPORTED DEVICE BEHAVIOR AND ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223351 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.