BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4934969 · Received July 23, 2015

    Report

    Report Number
    2032640-2015-00003
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    July 1, 2015
    Manufacturer
    PHILIPS HEALTHCARE / INNER COOL
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S FIELD SERVICE ENGINEER REPLACED THE MAIN PCBA AND VGA CONTROLLER PCBA TO ADDRESS THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WILL NOT BOOT UP. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481208 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS HEALTHCARE / INNER COOL V200

    Patients

    Seq Age Sex Outcome Treatment
    1