BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3944885 · Received July 18, 2014

    Report

    Report Number
    2031642-2014-00698
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE. OUT OF WARRANTY; NO REQUEST FOR MNF SERV.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING CHECKOUT THE VENTILATOR WENT VENT INOP DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. 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 DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS THE DEVICE IS OUT OF WARRANTY, THE FACILITY BIOMEDICAL ENGINEER CONTACTED MANUFACTURERS PRODUCT SUPPORT ENGINEER (PSE) FOR ASSISTANCE. THE BIOMEDICAL ENGINEER VERIFIED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE WAS SEATED. PSE ADVISED THE CUSTOMER EVALUATE THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE AND DATA ACQUISITION PCB BOARD FOR REPLACEMENT TO ADDRESS THE REPORTED PROBLEM. THE BIOMEDICAL ENGINEER WAS CONTACTED FOR FOLLOWUP WITH NO RESPONSE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421921 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1