BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 11308535 · Received February 10, 2021

    Report

    Report Number
    2031642-2021-00515
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 27, 2021
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:24FEB2021. B4:25FEB2021. 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 FEMALE 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 HIGH FLOW THERAPY VIA THE RESPIRONICS V60 VENTILATOR WITH A PHILIPS AC611 HIGH FLOW NASAL CANNULA MEDIUM OR LARGE SIZE; PRESCRIPTION, DEVICE SETTINGS, CONFIGURATION, AND PATIENT CIRCUIT WERE NOT REPORTED. WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS RECEIVING HIGH FLOW THERAPY VIA THE V60 DEVICE WITH AN APPROXIMATE FLOW RATE AT 50 LITERS PER MINUTE (L/MIN), THE DEVICE SEEMED TO STOP DELIVERING FLOW AND GENERATED A CANNOT REACH TARGET FLOW (122D) ALARM, AND THE PATIENT EXPERIENCED AN EVENT OF DECREASED PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2); VALUES NOT REPORTED. THE HOSPITAL STAFF THEN REPOSITIONED THE HIGH FLOW NASAL CANNULA WITHIN THE PATIENT¿S NARES, BROUGHT THE CIRCUIT CLOSER TO THE PATIENT¿S CHEST, SECURED IT, AND THE EVENT OF OXYGEN DESATURATION RESOLVED. NO RELEVANT LABORATORY DATA WAS REPORTED. 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 DELIVER 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 · 0

    G4:17MAR2021. B4:06APR2021. THE ROOT CAUSE OF THE DEVICE BEHAVIOR WAS DUE TO AN OCCLUSION OF THE HIGH FLOW NASAL CANNULA, WHICH WAS RESOLVED WHEN THE NASAL CANNULA WAS REPOSITIONED. 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

    EVENT DATE: (B)(6) 2021. REPORT DATE: 10FEB2021.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING HIGH FLOW THERAPY TO A PATIENT, THE RESPIRONICS V60 VENTILATOR SEAMED TO STOP DELIVERING FLOW, AND THE 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 SYMPTOM AND ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203557 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER| UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER