BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 2582086 · Received May 21, 2012

    Report

    Report Number
    2031642-2012-00218
    Event Type
    Injury
    Date Received
    May 21, 2012
    Date of Event
    April 22, 2012
    Report Date
    April 23, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DIRECTOR OF RESPIRATORY THERAPY (RT) REPORTED THE VENTILATOR ALARMED DUE TO OXYGEN NOT AVAILABLE WHILE TRANSPORTING THE PATIENT TO ICU VIA OXYGEN CYLINDER WITH REGULATOR. THE CUSTOMER REPORTED THE O2 TANK REGULATOR WAS OBSERVED TO BE FROZEN SOLID WHITE. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO A PATIENT. THE PATIENT WAS BAGGED THE REMAINDER OF THE TRANSPORT. THE RT DIRECTOR REPORTED THE PATIENT WAS IN CRITICAL CONDITION AND DETERIORATING RAPIDLY AND WAS LATER INTUBATED AND DIED A FEW HOURS LATER BUT STATED THE PATIENT WAS TERMINAL AND THE PATIENT'S DEATH WAS NOT A RESULT OF THE ISSUE DURING TRANSPORT BUT A RESULT OF THEIR CONDITION. THE MANUFACTURER'S SERVICE TECHNICIAN TESTED THE DEVICE USING THE CUSTOMER CIRCUIT AND PARAMETER SETTINGS. THE SERVICE TECHNICIAN REPORTED THE REGULATOR THAT WAS IN USE ON THE O2 CYLINDER FELT COOL TO THE TOUCH. THE SERVICE TECHNICIAN REPORTED THE DEVICE STARTING ALARMING O2 NOT AVAILABLE WHEN THE REGULATOR DROPPED BELOW 100 PSI. THE SERVICE TECHNICIAN REPORTED HE SWITCHED OUT THE O2 TANK FOR A FULL ONE AND THE DEVICE STOPPED ALARMING. THE DEVICE PASSED FULL PERFORMANCE VERIFICATION TESTING. REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED O2 NOT AVAILABLE ALARM OCCURRENCES. THE MANUFACTURER'S CLINICAL SPECIALIST DISCUSSED THE REPORTED EVENT WITH THE RT DIRECTOR AND EXPLAINED THE POSSIBILITY OF A RAPID PRESSURE DROP CAUSING A DROP IN TEMPERATURE IN HIGH HUMIDITY ENVIRONMENTS (EITHER HUMIDITY PRESENT IN THE REGULATOR OR HUMIDITY IN THE ROOM). SINCE THE CUSTOMER HASN'T OBSERVED THIS DURING OTHER TRANSPORTS, THE SPOTLIGHT APPEARED TO BE ON THE O2 REGULATOR, O2 TANK FILLING-PROCEDURE AND/OR ENVIRONMENT. ALTHOUGH THERE IS A TEMPERATURE CHANGE AT THE REGULATOR DURING USE THE MOISTURE BUILDUP AND REPORTED FREEZING OF THE REGULATOR WAS NOT ASSOCIATED WITH THE DEVICE DIRECTLY. THE DEVICE HAS BEEN PLACED BACK INTO USE WITH NO FURTHER ISSUES REPORTED.

    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 Required Intervention