BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 12643549 · Received October 15, 2021

    Report

    Report Number
    2031642-2021-05298
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 17, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FAILURE INVESTIGATION ENGINEER CONDUCTED A DEVICE EVALUATION ON 11-MAR-2022. THE POWER MANAGEMENT (PM) PCBA WAS INSTALLED IN THE FI TEST VENTILATOR ((B)(6)) IN AN ATTEMPT TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR WAS POWERED UP FROM AC AND DELIVERED BREATHS. IT DID NOT GENERATE 1009 DIAGNOSTIC ERROR CODES. THE POST WAS EXECUTED 25 TIMES WITHOUT GENERATING ANY FAILURES. THE AC LED INDICATOR TURNED ON AND THE VENTILATOR OPERATED FOR 2 HOURS WITHOUT FAILURES. THE SUPPLY VOLTAGES WERE WITHIN SPECIFICATIONS WITH THE FOLLOWING MEASUREMENTS. THE POWER MANAGEMENT (PM) PCBA WAS TESTED AND NO FAILURES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN WHILE IN USE ON A PATIENT, AND THE SCREEN WENT BLANK. THE DEVICE WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT. THE PATIENT WAS ADMITTED TO THE FACILITY (B)(6) 2021 WITH PRIMARY DIAGNOSIS OF COVID-19. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH, DYSPNEA WITH A NOTED RESPIRATORY RATE >40 BREATHES PER MINUTE, AND A SATURATION OF PERIPHERAL OXYGENATION (SPO2) OF 92% WHILE RECEIVING 100% FIO2 VIA A NON-REBREATHER MASK. THE PATIENT WAS PRESCRIBED BILEVEL VENTILATION VIA THE V60 VENTILATOR WITH SETTINGS TITRATED MULTIPLE TIMES THROUGHOUT THE DURATION OF THERAPY. ON (B)(6) 2021 AT 0343 THE DEVICE LOGGED A PRESSURE REGULATION HIGH EVENT AND WENT INOPERATIVE. A REGISTERED NURSE (RN) WAS PRESENT BEDSIDE AT THE TIME OF THE EVENT AND IMMEDIATELY CALLED FOR ASSISTANCE FROM A RESPIRATORY THERAPIST (RT). THE PATIENT WAS REMOVED FROM THE V60 VENTILATOR AND PROVIDED MANUAL VENTILATION VIA AMBU-BAG FOR APPROXIMATELY 30 SECONDS UNTIL A SECONDARY DEVICE WAS OBTAINED (MAKE/MODEL UNSPECIFIED), AND THE PATIENT WAS TRANSITIONED. THE PATIENT WAS NOTED TO HAVE CONTINUALLY DECLINED IN CONDITION AFTER THE EVENT WITH ARTERIAL BLOOD GAS VALUES ANALYSIS FOUND SEVERE HYPOXIA (46 MMHG) WHILE RECEIVING 100% FIO2. CUSTOMER STATES THAT THE PATIENT WAS SUBSEQUENTLY INTUBATED TO PROVIDE FURTHER CONTROL OF VENTILATION/OXYGENATION EFFORTS WITH NOTED STABILIZATION OF VITALS AT 0830. PATIENT SUBSEQUENT EXPIRATION CONFIRMED TO HAVE OCCURRED APPROXIMATELY 11 DAYS LATER ON (B)(6) 2021. AN AUTHORIZED SERVICE PROVIDER (ASP) EVALUATED THE VENTILATOR. THE ERROR LOG WAS REVIEWED AND A DIAGNOSTIC ERROR FOR PRESSURE REGULATION HIGH WAS PRESENT. THE ASP TESTED THE VENTILATOR AND COULD NOT DUPLICATE THE PRESSURE REGULATION HIGH ERROR. THE ASP REPLACED THE POWER MANAGEMENT BOARD AS A PREVENTATIVE MEASURE AND PERFORMED TESTING AGAIN. ALL TESTS PASSED. THE COMPLAINT OF VENTILATOR SHUT DOWN COULD NOT BE DUPLICATED. PERFORMANCE VERIFICATION TESTING WAS PERFORMED AND ALL TESTS PASSED. BASED ON INFORMATION PROVIDED AND/OR SERVICE PERFORMED, THE CUSTOMERS ALLEGATION WAS CONFIRMED BY THE PRESENCE OF THE ERROR PRESSURE REGULATION HIGH. PRESSURE REGULATION HIGH IS A DESIGN MITIGATION TO PREVENT PATIENT HARM. THE DEVICE FUNCTIONED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536730 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention