BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 12634261 · Received October 14, 2021

    Report

    Report Number
    2031642-2021-05292
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    October 5, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION HAS DISCOVERED THE DEVICE WAS IN CLINICAL USE PROVIDING THERAPY TO A COVID POSITIVE PATIENT IN AN ISOLATION ROOM AT THE TIME OF THE EVENT. THE PATIENT HAD BECOME DISCONNECTED FROM THE BREATHING CIRCUIT (NON-PHILIPS PRODUCT) AND BEGAN AUDIBLY CALLING FOR CLINICAL ASSISTANCE. UPON DISCOVERY OF THE DISCONNECTION, THE INSTITUTIONAL CLINICIAN HAD FOUND THE PATIENT EXHIBITING DYSPNEA AND MILD CYANOSIS. THE PATIENT WAS MANUALLY VENTILATED AND SUBSEQUENTLY PLACED BACK ONTO THE DEVICE. NO FURTHER HARM OR INJURY HAD BEEN NOTED. FURTHER INVESTIGATION HAS DETERMINED THAT THE DEVICE FUNCTIONED AS DESIGNED WITH NO FAILURE OR MALFUNCTION NOTED BY THE INSTITUTIONAL BIOMEDICAL ENGINEER. DUE TO THE DISCONNECTION OF THE BREATHING CIRCUIT (NON-PHILIPS PRODUCT) FROM THE V60 DEVICE OUTLET PORT, THE PATIENT EXPERIENCED DYSPNEA AND MILD CYANOSIS RESULTING IN THE NEED FOR MEDICAL INTERVENTION VIA MANUAL VENTILATION UNTIL THE DEVICE WAS RECONNECTED TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THERAPEUTIC USE OF THE V60 VENTILATOR, AN ERROR CODE OF 110D (PROXIMAL PRESSURE RANGE ERROR) HAD OCCURRED. ADDITIONALLY, IT WAS STATED THAT THE DEVICE DID NOT PRODUCE AN ALARM WHEN THE BREATHING CIRCUIT WAS DISCONNECTED. FURTHER INVESTIGATION IS PENDING TO CLARIFY THE PROBLEM WITH THE CUSTOMER. THE DEVICE WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE REPORTED EVENT. THE PATIENT IS NOTED TO HAVE BEEN CYANOTIC. FURTHER INVESTIGATION IS CURRENTLY PENDING. THE DEVICE WAS EVALUATED AND INVESTIGATED BY THE INSTITUTIONAL BIOMEDICAL ENGINEER. THE DIAGNOSTIC REPORT WAS RETRIEVED AND FORWARDED TO PHILIPS AND PERFORMANCE VERIFICATION TESTING (PVT) CONDUCTED IN ADDITION TO DEVICE RUN-IN TESTING FOR APPROXIMATELY 8+ HOURS. DIAGNOSTIC REPORT ANALYSIS CONFIRMED A SOLITARY OCCURRENCE OF THE 110D ERROR CODE. PVT WAS CONDUCTED WITH NO FAULT FOUND AND VERIFICATION OF THE DEVICES ABILITY TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS. ADDITIONAL VERIFICATION TESTING CONFIRMED AUDIBLE AND VISUAL ALARMS FOR BOTH PATIENT DISCONNECTION AND PROXIMAL PRESSURE LINE DISCONNECTION ALARMS. THE DEVICE HAS SUBSEQUENTLY BEEN RELEASED AND RETURNED TO FULL CLINICAL SERVICE WITH NO FAULT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532300 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention