BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6504595 · Received April 19, 2017

    Report

    Report Number
    2031642-2017-01388
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Report Date
    March 31, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS IS NOT A REPORTABLE MALFUNCTION. THE PRESSURE RELIEF VALVE (PRV) IS A 3RD LEVEL (REDUNDANT) MECHANISM. NEED 3 INDEPENDENT FAILURES FOR IT TO BECOME A REPORTABLE ISSUE. THE CUSTOMER WAS ADVISED TO ADJUST THE PRV AND PROVIDED THE CUSTOMER MANUAL REFERENCE TO ADJUSTMENT PROCEDURES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UNIT FAILED EXTENDED SELF-TEST (EST) FOR PRESSURE RELIEF VALVE (PRV). CUSTOMER REPORTED PRV CRACKING PRESSURE WITH THE GAS OUTLET PORT OCCLUDED IS 115CMH2O. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284560 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1