BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 6943925 · Received October 12, 2017

    Report

    Report Number
    2031642-2017-03250
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 12, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Removal / Correction Number
    Z-2061-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS REPORTED THAT THE VENTILATOR STOPPED TWICE AND DISPLAYED AN ERROR CODE (EC #1006-DEVICE INOPERABLE) A NURSE REPORTED THAT A PATIENT REQUIRED VENTILATION AT HOME BEFORE ARRIVING THE HOSPITAL DUE TO RESPIRATORY DISTRESS. THE CARDIOLOGIST THAT WAS PRESENT PRESSED THE ON BUTTON AND THE DEVICE RESTARTED AND STOPPED AGAIN. THE PATIENT RAPIDLY DE-SATURATED, HOWEVER, THE MEDICAL TEAM WAS PRESENT AND WERE ABLE TO RESUSCITATE. THE PATIENT WAS ADMITTED TO THE CARDIOLOGY DEPARTMENT. THE DRPT (DAILY REPORT) LOGS WERE RECEIVED AND REVIEWED BY THE ENGINEER ELECTRICAL PRINCIPAL. THE REPORTED ERROR CODES WERE FOUND IN THE LOGS, AND IT WAS ALSO DISCOVERED THAT THE VENTILATOR SEEMS TO HAVE BEEN ALARMING TIDAL VOLUME AND RATE ALARMS CONSTANTLY PRIOR TO THE INCIDENT. THE DATA ACQUISITION PRIMARY CIRCUIT BOARD AND MOTOR CONTROL PRIMARY CIRCUIT BOARDS CABLES WERE REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE ORIGINAL FOLLOW UP REPORT STATE THE FOLLOWING: "THE DATA ACQUISITION PRIMARY CIRCUIT BOARD AND MOTOR CONTROL PRIMARY CIRCUIT BOARDS CABLES WERE REPLACED." THIS STATEMENT HAS BEEN CORRECTED TO THE FOLLOWING: THE DA-MC(DATA ACQUISITION TO MOTOR) CABLE WAS REPLACED PER A FIELD CHANGE ORDER (FCO #86600037).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. PATIENT INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE VENTILATOR STOPPED WORKING AND DID NOT ALARM. A PATIENT WAS ON THE VENTILATOR AND DESATURATED QUICKLY. FURTHER DATA HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724736 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention