BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3951479 · Received July 22, 2014

    Report

    Report Number
    2031642-2014-00715
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 30, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RCVD BY MFR: 09/08/2014. CONCLUSION / ROOT CAUSE: THE DATA ACQUISITION WAS TESTED AND NO FAILURES WERE IDENTIFIED. THE 1007, 1110, 110E, 110F & 1113 ERROR CODES COULD NOT BE DUPLICATED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE DEVICE DISPLAYED PRESSURE SENSORS FAILURE AT STARTUP AND DIAGNOSTIC HISTORY INCLUDED CODES THAT INDICATED A SPI BUS FAILURE. THE SPI BUS IS COMMUNICATION USED TO READ DATA FOR PRESSURE AND FLOW SENSORS. THIS FAILURE MAY RESULT IN A VENT INOP OCCURRENCE. 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 CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPLACED THE DATA ACQUISITION PCB BOARD TO ADDRESS THE REPORTED PROBLEM. FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428995 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1