BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 / ESPRIT

    MDR report key: 11499688 · Received March 16, 2021

    Report

    Report Number
    2031642-2021-03018
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 15, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 15FEB2021. G5: 510K: K102054. B4: 24JUN2021. DEVICE IDENTIFIER (GTIN): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT DURING TESTING THE TOUCHSCREEN WAS NOT FUNCTIONING. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND IT WAS DETERMINED THAT THE TOUCHSCREEN NEEDED TO BE REPLACED TO RETURN THE DEVICE TO WORKING CONDITION. THE FSE REPLACED THE TOUCHSCREEN TO RESOLVE THE ISSUE AND BRING THE DEVICE BACK TO FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394391 V200 / ESPRIT VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1