BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V200 VENTILATOR

    MDR report key: 3932373 · Received July 14, 2014

    Report

    Report Number
    2031640-2014-00668
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 30, 2014
    Manufacturer
    REPIRONICS CALIFORNIA INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE TEMPERATURE OF THE HUMIDIFIED GAS TO THE PATIENT VIA THE VENTILATOR WAS TOO HIGH AND THE HOSPITAL NURSE REPORTED IT HURT THE PATIENT'S MUCOUS MEMBRANE OF THE RESPIRATORY. THE HOSPITAL DECLINED TO PROVIDE FURTHER PATIENT INFORMATION. THE MANUFACTURERS FIELD SERVICE ENGINEER CHECKED THE VENTILATOR AND REPORTED NO MALFUNCTION OF THE VENTILATOR WAS FOUND. THE SERVICE ENGINEER REPORTED THE LIGHT ON THE HUMIDIFIER IN USE WAS NOT WORKING. THE HOSPITAL DIRECTOR TESTED THE VENTILATOR AND FOUND NO PROBLEM OR MALFUNCTION. THE HOSPITAL INFORMED THE PATIENTS RELATIVES OF THE PATIENT INJURY BUT DID NOT SAY THE VENTILATOR CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411311 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK REPIRONICS CALIFORNIA INC V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FISHER &PAYKEL MR310 HUMIDIFIER