BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 9043339 · Received September 13, 2019

    Report

    Report Number
    2031642-2019-09226
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    November 13, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018, DATE OF REPORT: 09/13/2019. 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. PHILIPS TECHNICAL SUPPORT RECOMMENDED THAT THE CUSTOMER TO REPLACE PRV. THE CUSTOMER REPLACED THE BLOCK ASSEMBLY AND RETESTED THE EST AND PASSED THE EST AND ALL TESTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS PRV IS LIMITED TO 70-80 CMH2O AFTER REPLACING THE POPPET. THERE WAS NO PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826535 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1