BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6798198 · Received August 16, 2017

    Report

    Report Number
    2031642-2017-02616
    Event Type
    Malfunction
    Date Received
    August 16, 2017
    Report Date
    July 24, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Removal / Correction Number
    Z-2061-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL FOLLOW UP WAS PERFORMED CONCERNING THE REPORT, IT WAS CLARIFIED THAT THE CALL FROM THE ACCOUNT WAS AN INQUIRY CONCERNING THE IMPLEMENTATION OF Z-2061-2017 AND THERE WAS NO ALLEGATION OF A COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UNIT HAS AN ERROR CODE MESSAGE OF MACHINE AND PROXIMAL PRESSURE SENSORS FAILED. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577494 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1