BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 12196328 · Received July 20, 2021

    Report

    Report Number
    2031642-2021-04362
    Event Type
    Death
    Date Received
    July 20, 2021
    Date of Event
    July 15, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH IMPACT CODE IS UPDATED.

    Additional Manufacturer Narrative · 0

    B4:14AUG2021. FURTHER INVESTIGATION GOOD FAITH EFFORTS HAVE BEEN UNSUCCESSFUL WITH THE CUSTOMER UNABLE TO DIVULGE FURTHER CONTEXTUAL INFORMATION REGARDING THE EVENT IN QUESTION. DEVICE FULL FUNCTIONALITY AND PERFORMANCE TO MANUFACTURER DECLARED SPECIFICATIONS HAS BEEN CONFIRMED VIA PHILIPS FIELD SERVICE ENGINEER INVESTIGATION OF THE DEVICE AND PERFORMANCE VERIFICATION TESTING. DUE TO THE LACK OF FURTHER INFORMATION BEING PROVIDED BY THE CUSTOMER, CONTRIBUTION OF THE DEVICE PERFORMANCE AND THE PATIENT OUTCOME CANNOT BE FURTHER DETERMINED. BASED UPON THE INFORMATION PROVIDED, ROOT CAUSE OF THE PATIENT EXPIRATION CANNOT BE DETERMINED. FULL FUNCTIONALITY OF THE V60 VENTILATOR AND PERFORMANCE TO MANUFACTURER DECLARED SPECIFICATIONS HAS BEEN VERIFIED.

    Additional Manufacturer Narrative · 1

    REPORT DATE: 20JUL2021. (B)(4).

    Description of Event or Problem · 1

    DURING THERAPEUTIC USE, IT WAS STATED BY AN INSTITUTIONAL NURSE THAT THE V60 VENTILATOR FAILED TO PROVIDE AN ALARM NOTIFICATION (UNSPECIFIED IF AUDIO, VISUAL, OR BOTH HAD FAILED). THE DEVICE WAS IN USE PROVIDING THERAPY AT THE TIME OF THE REPORTED EVENT. IT WAS NOTED BY THE CUSTOMER THAT THE PATIENT SUBSEQUENTLY EXPIRED. THE EVENTS SURROUNDING THE PATIENT EXPIRATION, INTERVENTIONS REQUIRED, OR DEVICE MALFUNCTION AT THE TIME OF THE EVENT IS CURRENTLY PENDING FURTHER INVESTIGATION. THE DEVICE HAS BEEN REMOVED FROM CLINICAL SERVICE AND HAS BEEN EVALUATED BY AN INSTITUTIONAL BIOMEDICAL ENGINEER (BME). THE BME STATED THAT PRELIMINARY TESTS HAVE FOUND NO FAILURE OR MALFUNCTION WITH THE REPORTED DEVICE, CONFIRMING ALARM EFFICACY AND FUNCTIONALITY. THE DEVICE HAS BEEN SEQUESTERED AND IS CURRENTLY AWAITING FURTHER VERIFICATION BY A PHILIPS FIELD SERVICE ENGINEER (FSE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095874 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death