BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 8958431 · Received September 3, 2019

    Report

    Report Number
    2031642-2019-07901
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Report Date
    July 20, 2018
    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) 2018. DATE OF REPORT: 09/03/2019. CUSTOMER FOUND DURING TROUBLE SHOOTING: PRESSURE RELIEF VALVE (PRV) IS POPPING OFF AT 40 CMH2O. ADVISED CUSTOMER TO REPLACE THE PRV SINCE IT WILL NOT ADJUST TO THE CORRECT PRESSURE. CUSTOMER REPORTED REPLACING THE PRV RESOLVED THE ISSUE. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ACCURACY TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750759 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1