BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 11287243 · Received February 5, 2021

    Report

    Report Number
    2031642-2021-00441
    Event Type
    Death
    Date Received
    February 5, 2021
    Date of Event
    January 27, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:15FEB2021. B4:19FEB2021. H11:G5: K102985. 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 62 YEARS OLD FEMALE PATIENT OF UNKNOWN HEIGHT, AND WEIGHT WAS ADMITTED TO A HOSPITAL ON AN UNKNOWN DATE WITH AN ADMITTING DIAGNOSIS OF CORONAVIRUS (COVID 19) AND PNEUMONIA. RELEVANT MEDICAL HISTORY INCLUDED NON-OBESE WITH NO COMORBIDITIES. NO 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) VIA THE FISHER AND PAYKEL AIRVO, WITH FISHER AND PAYKEL OPTIFLOW MEDIUM SIZE HIGH FLOW NASAL CANNULA, AT 60 LITERS PER MINUTE (L/MIN), AND 100% FRACTION OF INSPIRED OXYGEN (FIO2). WHILE ADMITTED ON (B)(6) 2021, THE PATIENT WAS IN THE SEMI-FOWLER'S POSITION RECEIVING HFT VIA THE FISHER AND PAYKEL, THE PATIENT'S PERIPHERAL OXYGEN CAPILLARY SATURATION (SPO2) WAS 88%, HOSPITAL STAFF THEN PLACED THE PATIENT ON THE V60 PLUS VIA A PHILIPS AC611 MEDIUM SIZE HIGH FLOW NASAL CANNULA; PATIENT CIRCUIT AND HUMIDIFIER NOT REPORTED, AT 80 L/MIN, 100%FIO2, AND THE PATIENT¿S SPO2 INCREASED INTO THE 90S. THE PATIENT THEN COUGHED, THE V60 PLUS GENERATED A CANNOT REACH TARGET FLOW (122D) ALARM, THE FLOW RATE DROPPED TO 40 L/MIN, THE PATIENT DESATURATED TO THE 70S SPO2, THE FLOW RATE THEN INCREASED INCREMENTALLY TO 80 L/MIN, AND THE OXYGEN SATURATION IMPROVED; VALUES NOT REPORTED. THE PATIENT THEN COUGHED AGAIN, THE DEVICE GENERATED ANOTHER 122D ALARM, THE PATIENT DESATURATED TO THE 70S SPO2, THE HOSPITAL STAFF PLACED THE PATIENT BACK ON THE FISHER AND PAYKEL AIRVO WITH FISHER AND PAYKEL OPTIFLOW MEDIUM SIZE HIGH FLOW NASAL CANNULA AT 60 L/MIN AND 100% FIO2, BUT THE SPO2 DID NOT IMPROVE FROM THE 70S. HOSPITAL STAFF THEN INTUBATED THE PATIENT, PLACED THE PATIENT ON MECHANICAL VENTILATION; BRAND, MODEL, AND PRESCRIPTION NOT REPORTED, AND THE PATIENT EXPERIENCED AN OUTCOME OF DEATH SEVEN DAYS LATER. THE REPORTER STATED THAT THE OUTCOME WAS NOT RELATED TO THE V60 VENTILATOR, BUT TO THE PATIENT'S ADMITTING DIAGNOSIS. 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

    EVENT DATE: (B)(6) 2021. REPORT DATE: 05FEB2021 .

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING HIGH FLOW THERAPY TO A PATIENT, THE RESPIRONICS V60 VENTILATOR GENERATED CANNOT REACH TARGET FLOW ALARMS, 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 BEHAVIOR AND ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180581 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT V60

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.| UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER