BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 12434136 · Received September 7, 2021

    Report

    Report Number
    2031642-2021-04836
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    August 30, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE GOOD FAITH EFFORTS TO OBTAIN FURTHER INFORMATION REGARDING THE ALLEGATION HAVE BEEN UNSUCCESSFUL. DEVICE EVALUATION, PATIENT OUTCOME, AND ROOT CAUSE COULD NOT BE CONCLUDED DUE TO A LACK OF FURTHER INFORMATION. SHOULD FURTHER INFORMATION BE PROVIDED BY THE CUSTOMER, THE COMPLAINT RECORD SHALL BE REOPENED.

    Additional Manufacturer Narrative · 1

    DATE SUBMITTED: 07SEP2021.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO PHILIPS THAT WHILE DELIVERING HIGH FLOW THERAPY TO A PATIENT, THE RESPIRONICS V60 VENTILATOR KEPT STOPPING MULTIPLE TIMES WHEN HOSPITAL STAFF NEED TO INCREASE THE FLOW RATE FROM 30 LITERS PER MINUTE (LPM) AT 90% FRACTION OF INSPIRED OXYGEN (FIO2) TO 40 LPM, AND THE PATIENT EXPERIENCED AN EVENT OF DECOMPENSATION, OXYGEN DESATURATION, AND ALMOST EXPERIENCED A CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON A PATIENT AT THE TIME OF THE DEVICE BEHAVIOR AND ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331685 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention