BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 9673404 · Received February 5, 2020

    Report

    Report Number
    2031642-2020-00412
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Report Date
    January 15, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 02/05/2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD AN ERROR CODE INDICATING A PRESSURE RELIEF VALVE (PRV) CRACKING PRESSURE OUT OF RANGE. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER TROUBLESHOT WITH TECHNICAL SUPPORT. THE CUSTOMER STATED THAT THE SPRING TO THE ORIGINAL PRESSURE RELIEF VALVE (PRV) WAS PHYSICALLY DAMAGED. THE CUSTOMER REPORTED THAT REPLACING THE PRV ADDRESSED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137855 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1