BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4093373 · Received September 16, 2014

    Report

    Report Number
    2031642-2014-01046
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PCB BOARD AND CABLE RESEATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP DUE TO A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. A DATA ACQUISITION PCBA ADC REFERENCE FAILURE DURING NORMAL VENTILATION OPERATION MAY RESULT IN A VENT INOP CONDITION. A VENT INOP 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) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED A VENT INOP OCCURRENCE AS REPORTED BY THE CUSTOMER. THE FSE INSPECTED AND RESEATED THE POWER MANAGEMENT PCB BOARD AND DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB BOARD CABLE. THE FSE REPORTED TESTING PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571433 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1