BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 13359511 · Received January 26, 2022

    Report

    Report Number
    2031642-2022-00256
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    December 22, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED UPON THE INFORMATION PROVIDED, THE COMPLAINT RECORD SHALL BE REPORTED TO RELEVANT COMPETENT AUTHORITIES AS A PATIENT SERIOUS INJURY DUE TO THE REQUIRED MEDICAL INTERVENTION, INTUBATION, AND ESCALATION TO AN INTENSIVE CARE UNIT.

    Description of Event or Problem · 0

    (B)(6) WAS MADE AWARE THAT DURING CLINICAL AND THERAPEUTIC USE OF THE V60 VENTILATOR, A PATIENT HAD DISCONNECTED THEMSELVES FROM THE VENTILATOR, RESULTING IN AN UNANTICIPATED CHANGE IN CONDITION REQUIRING MEDICAL INTERVENTION, ADVANCED AIRWAY PLACEMENT VIA ENDOTRACHEAL TUBE, AND ESCALATED CARE TO AN INTENSIVE CARE UNIT (ICU). SEVERAL WEEKS AFTER THE EVENT IN QUESTION, THE PATIENT WAS WITHDRAWN FROM MECHANICAL VENTILATION AND SUBSEQUENTLY EXPIRED. THE V60 VENTILATOR WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT. DEVICE SETTINGS WERE AS FOLLOWS: MODE S/T, IPAP 12 CMH2O, EPAP 6 CMH2O, RESPIRATORY RATE 16 BREATHES PER MINUTE, FIO2 100%. THE PATIENT WAS NOTED AS A MALE, LATE 50'S TO EARLY 60'S YEARS OF AGE, PRIMARY DIAGNOSIS OF COVID-19 WITH HYPOXEMIC RESPIRATORY FAILURE. INVESTIGATION INTO THE EVENT AND ACCOUNTS PROVIDED BY THE INSTITUTIONAL RESPIRATORY THERAPY MANAGER STATE THAT THE PATIENT WAS NON-COMPLIANT AND HAD BEEN OBSERVED REMOVING THEIR NON-INVASIVE INTERFACE MULTIPLE TIMES THROUGHOUT THE DURATION OF THERAPY. DURING THE EVENT IN QUESTION, THE PATIENT HAD REMOVED THE NON-INVASIVE INTERFACE (MAKE/MODEL UNSPECIFIED) AND DUE TO THEIR POOR CLINICAL STATUS DECLINED QUICKLY. AN INSTITUTIONAL RAPID RESPONSE WAS CALLED, AND THE PATIENT WAS SUBSEQUENTLY INTUBATED AND TRANSFERRED TO THE ICU. THE DEVICE WAS INSPECTED BY AN INSTITUTIONAL BIOMEDICAL ENGINEER. DIAGNOSTIC REPORTS WERE RETRIEVED FROM THE DEVICE AND FURNISHED TO PHILIPS. FURTHER EVALUATION OF THE V60 VENTILATOR AND DEVICE THERAPY TESTING VIA A TEST LUNG FOR APPROXIMATELY 1 HOUR YIELDED NO FINDINGS OF MALFUNCTION OR FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS, WITH ALL ALARMS AND FUNCTIONALITY OF THE V60 VENTILATOR CONFIRMED. BASED UPON THE FINDINGS WITHIN THE DIAGNOSTIC REPORT AND THE EVALUATION OF THE V60 VENTILATOR BY THE INSTITUTIONAL BIOMEDICAL ENGINEER, NO MALFUNCTION OR FAILURE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS HAS BEEN NOTED. BASED UPON THE INFORMATION PROVIDED, THE DEVICE DID NOT CAUSE NOR CONTRIBUTE TO THE PATIENT OUTCOME. NO ALLEGATION OF CAUSE AND/OR CONTRIBUTION HAS BEEN LODGED BY THE INSTITUTION. THE ROOT CAUSE OF THE PATIENT EVENT WAS DUE TO UNINTENTIONAL REMOVAL OF THE NON-INVASIVE INTERFACE BY THE PATIENT DURING POSITIVE PRESSURE THERAPY RESULTING IN A RAPID DECLINE IN PATIENT CONDITION AND THE NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621761 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC USED V60 PLUS VENTILATOR, US

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention