BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6812873 · Received August 23, 2017

    Report

    Report Number
    2031642-2017-02696
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Report Date
    July 26, 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
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED DURING OPERATION WITH DUE TO A DATA ACQUISITION PCB ADC REFERENCE FAILURE. THE DEVICE WAS SWITCHED OFF AND ON AGAIN AND A MACHINE AND PROXIMAL PRESSURE SENSOR FAILURE APPEARED. THERE WAS PATIENT INVOLVEMENT. PATIENT INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE DEVICE ALARMED WHEN THE DATA ACQUISITION PCB ADE REFERENCE FAILURE OCCURRED. THE DEVICE WAS BEING USED IN THE VENTILATION MODE NON INVASIVE VENTILATION S/T. THE PATIENT WAS PLACED ON ANOTHER DEVICE. THERE WAS PATIENT INVOLVEMENT. PATIENT INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE DEVICE ALARMED WHEN THE DATA ACQUISITION PCB ADE REFERENCE FAILURE OCCURRED. THE DEVICE WAS BEING USED IN THE VENTILATION MODE NON INVASIVE VENTILATION S/T. THE PATIENT WAS PLACED ON ANOTHER DEVICE. THERE WAS PATIENT INVOLVEMENT. PATIENT INFORMATION HAS BEEN REQUESTED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595708 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1