BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 9677626 · Received February 6, 2020

    Report

    Report Number
    2031642-2020-00421
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Report Date
    January 23, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 06FEB2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS FAILING EXTENDED SELF TEST (EST) AT THE PRESSURE RELIEF VALVE (PRV) TEST. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER TROUBLESHOT WITH TECHNICAL SUPPORT AND VERIFIED THAT PRV CRACKING PRESSURE IS IN TOLERANCE AT 135. THE CUSTOMER FOUND A LEAK. THE CUSTOMER REMOVED THE LEAK BY USING A PATIENT CIRCUIT THAT DID NOT HAVE A LEAK AND THE UNIT PAST THE EST PRV TEST. THE LEAK WAS RESOLVED AT THE PATIENT CIRCUIT AND THE ISSUE WAS ADDRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142856 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1