BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6145294 · Received December 5, 2016

    Report

    Report Number
    2031642-2016-03331
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 8, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. DATE OF EVENT REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION & RESOLUTION: THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE WIGGLED THE DA TO MC CABLE AND CAUSED VENT INOP. THE FSE REPLACED DA TO MC CABLE PER (B)(4) TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WENT VENT INOP WHILE IN USE. DUE TO A VENT INOP CONDITION, PRESSURE SENSORS FAILURE OCCURRENCE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794783 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1