BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3933011 · Received July 14, 2014

    Report

    Report Number
    2031642-2014-00670
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 18, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR DATE: 09/04/2014. THE DATA ACQUISITION PCBA AND DATA ACQUISITION PCBA TO MOTOR CONTROLLER PCBA CABLE WERE 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 THAT THE VENTILATOR ALARMED AND WENT VENT INOP DUE TO A DATA ACQUISITION PCBA ADC FAILURE. THE CUSTOMER REPORTED THE UNIT WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. 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 MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB BOARD CABLE AND DATA ACQUISITION PCB BOARD TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410808 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1