BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11953320 · Received June 7, 2021

    Report

    Report Number
    2031642-2021-03991
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102054. B4:12AUG2021.

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985. B4:12AUG2021. THE CUSTOMER EVALUATED THE DEVICE WITH ASSISTANCE FROM A PHILIPS REMOTE SERVICE ENGINEER (RSE). THE RSE REVIEWED THE ERROR LOGS, AND THE OCCURRENCE OF THE ERROR CODE INDICATING A 24-VOLT FAILURE WAS CONFIRMED. THE RSE ADVISED CHECKING THE POWER CORD. IF NO PROBLEMS ARE FOUND WITH THE CORD, THEN THE POWER SUPPLY MAY BE REQUIRED. THE CUSTOMER WAS ALSO ADVISED THAT PARTS HAVE LIMITED AVAILABILITY DUE TO THE DEVICE BEING AT THE END OF LIFE; THE RSE PROVIDED PART ID FOR THE POWER SUPPLY. THE CUSTOMER DECIDED TO RETIRE THE DEVICE, AND IT WAS REMOVED FROM SERVICE. AFTER TROUBLESHOOTING, THE CUSTOMER DECIDED TO RETIRE THE DEVICE, THERE WAS NO FURTHER INVESTIGATION, AND THE ROOT CAUSE WILL NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION, THE ISSUE OCCURRED OUTSIDE OF CLINICAL USE AND IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INQUIRY. THEREFORE, THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A RE-START UP COUNTDOWN. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841655 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown