BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3833404 · Received May 27, 2014

    Report

    Report Number
    2031642-2014-00395
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    April 30, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR DISPLAYED A DATA ACQUISITION PCBA ADC REFERENCE FAILURE DURING PRE-OPERATIONAL CHECKOUT. THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED A VENT INOP DATA ACQUISITION PCBA ADC REFERENCE FAILURE OCCURRENCE AS REPORTED. A VENT INOP CONDITION DURING OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE MANUFACTURER'S FIELD SERVICE ENGINEER REPORTED THE POWER MANAGEMENT PCB BOARD WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. FINAL TESTING WAS COMPLETED TO OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310883 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1