BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3930217 · Received July 11, 2014

    Report

    Report Number
    2031642-2014-00660
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE: 09/04/2014. CONCLUSION / ROOT CAUSE: THE MOTOR CONTROLLER (MC) PCBA WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED WITH PRESSURE SENSORS FAILURE AND CALIBRATION ERRORS. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. PER FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE REPORTED PROBLEM, BUT NOTED THE ERRORS IN THE DIAGNOSTIC LOG. REVIEW OF THE DEVICE DIAGNOSTIC CODES INDICATED A FAILURE OF THE INTERNAL COMMUNICATION LINK BETWEEN CPU AND GAS DELIVERY SYSTEM, WHICH MAY RESULT IN A VENT INOP CONDITION. A VENT INOP DURING NORMAL VENTILATION 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 FIELD SERVICE ENGINEER (FSE) INSPECTED THE DATA ACQUISITION TO MOTOR CONTROLLER CABLE AND RESEATED THE DATA ACQUISITION BOARD. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MOTOR CONTROLLER BOARD. THE UNIT PASSED ALL APPLICABLE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405881 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1