BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2110721 · Received June 1, 2011

    Report

    Report Number
    2031642-2011-00183
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN AND ALARMED DURING USE ON A PATIENT WHEN THE VENTILATOR CIRCUIT WAS REMOVED AND THEN RECONNECTED. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED EVENT. THE SERVICE TECHNICIAN REPLACED THE POWER MANAGEMENT AND MOTOR CONTROLLER PCB BOARDS TO ADDRESS THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1