BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11580466 · Received March 28, 2021

    Report

    Report Number
    2031642-2021-03155
    Event Type
    Malfunction
    Date Received
    March 28, 2021
    Date of Event
    February 26, 2021
    Report Date
    September 15, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER COULD NOT CONFIRM THE REPORTED FAILURE. THE UNIT FUNCTIONED AS DESIGNED. THE HOSPITAL HAD A THIRD PARTY COME IN AND REPAIR THEIR GAS LINES. THERE WERE NO PARTS REPLACED. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    G5:510(K)#:K102054. B4:13AUG2021. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED FAILURE. THE (FSE) REPLACED THE GAS DELIVERY SYSTEM (GDS) TO RESOLVE THE ISSUE. THE UNIT WAS TESTED AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW OXYGEN. THE UNIT WAS NOT IN USE, AND THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477496 RESPIRONICS VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, LLC ESPRIT VENTILATOR V1000

    Patients

    Seq Age Sex Outcome Treatment
    1