BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4111345 · Received September 23, 2014

    Report

    Report Number
    2031642-2014-01089
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING REPAIR FROM MANUFACTURER SERVICE ENGINEER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS HAVING POWER ISSUES. THE CUSTOMER HAD CONTACTED MANUFACTURERS SERVICE PREVIOUSLY ABOUT THE REPORTED PROBLEM. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE CUSTOMER PREVIOUSLY REPORTED THAT THE VENTILATOR ALARMED DUE TO A 12 VOLT SUPPLY FAILURE. A 12 VOLT SUPPLY FAILURE MAY RESULT IN A VENT INOP CONDITION DURING NORMAL VENTILATION MODE OPERATION. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. THE PRODUCT SUPPORT REVIEWED THE DEVICE DIAGNOSTIC HISTORY AND NOTED A 12VOLT SUPPLY FAILURE AS REPORTED. THIS UNIT IS PENDING REPAIR FROM THE SERVICE TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589551 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1