BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3900824 · Received June 27, 2014

    Report

    Report Number
    2031642-2014-00571
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHUTS DOWN DURING TRANSPORT OF A PATIENT. THERE WAS NO PATIENT HARM REPORTED. THE UNIT WAS REMOVED FROM SERVICE AND TESTED IN THE BATTERY MODE BY THE CUSTOMER. THE CUSTOMER REPORTED THE UNIT POWERED UP AND BEGAN OPERATING WITHOUT INCIDENT DURING BATTERY TESTING. THE DIAGNOSTIC MENU SHOWS THE BATTERY VOLTAGE AT 16.32VDC AND THE INDICATOR READS 100% CAPACITY. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND COULD NOT DUPLICATE THE REPORTED PROBLEM. DURING REVIEW OF THE DIAGNOSTIC LOG. THE FSE NOTED A CODE INDICATING A DATA ACQUISITION PCBA ADC REFERENCE FAILED FROM THE DAY OF THE REPORTED PROBLEM. A DATA ACQUISITION PCBA ADC REFERENCE FAILED. PRECLUDES SAFE OPERATION OF THE VENTILATOR; A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PATIENT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT. USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE FSE VERIFIED ALL VOLTAGE IN DIAGNOSTICS. CHECKED AND CONFIRMED THAT THE CABLE FROM DA PCBA TO MC PCBA WAS PROPERLY SEATED. PRIOR TO THE FSE ARRIVAL THE BIOMEDICAL ENGINEER REPORTED THE UNIT HAS BEEN RUNNING FOR OVER TWO DAYS WITH NO REOCCURRENCE OF THE REPORTED PROBLEM. THE UNIT WAS PLACED BACK INTO SERVICE. PERFORMED PERFORMANCE VERIFICATION TEST AND UNIT PASSED SUCCESSFULLY. NO PROBLEM FOUND, NO PARTS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377339 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1