BEUDAMED
    20 results · 69ms · Sources: EU EUDAMED, US FDA

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    INOMAX

    FDA Adverse Event
    INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·November 6, 2014

    INOMAX DSIR

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·September 11, 2015

    INOMAX DSIR

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·March 16, 2013

    INOMAXDS

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA,·Product code MRN·March 11, 2014

    INOVENT

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·January 31, 2014

    INOMAXDS

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·March 11, 2014

    INOMAX DSIR

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·June 3, 2013

    INOMAX DSIR

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·June 3, 2013

    INOMAX DSIR

    FDA Adverse Event
    Death ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·September 22, 2014

    INOMAX

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS, LLC/DBA IKARIA·Product code MRN·October 6, 2014

    INOMAX INOVENT

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·June 10, 2014

    INO MAX DSIR

    FDA Adverse Event
    INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·September 20, 2013

    INO MAX DSR

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·September 17, 2015

    INOMAX

    FDA Adverse Event
    INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·February 4, 2015

    INOVENT

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·April 2, 2015

    INOMAX DS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·October 29, 2015

    INOMAX DSIR

    FDA Adverse Event
    Malfunction ·INO THERAPEUTICS LLC/DBA IKARIA·Product code MRN·December 8, 2015

    Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode.

    FDA Recall
    Terminated ·INO therapeutics LLC/dba ikaria·Product code MRN·July 9, 2018

    Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flow of the nitric oxide in nitrogen compressed gas. The nitric oxide gas is administered to a patient via a nitric oxide delivery device. The amount of time that gas flow administered to a patient is captured in the INOmeter. Each INOmeter is programmed to include the drug product expiration date as listed on the INOflo drug product label. The INOmeter electronically communicates to the nitric oxide delivery device via infrared technology by way of the iButton and in so communicates the expiration date of the corresponding cylinder of INOflo drug product to the delivery device. The delivery device evaluates and compares the expiration date to the current date of therapy administration. If the drug product expiration date is prior to the current date, an error and alarm is registered by the nitric oxide delivery device and administration of the expired drug to the patient is stopped after 120 seconds. If this occurs, the healthcare provider can operate the nitric oxide delivery device manually and deliver the INOflo as indicated in the Instructions For Use (IFU). The INOflo delivery device has the functionality to administer INOflo in manual mode.

    FDA Enforcement
    Class II ·Terminated·INO therapeutics LLC/dba ikaria·August 15, 2018

    INOVENT

    FDA Adverse Event
    Malfunction ·INO THEREPEUTICS LLC/DBA IKARIA·Product code MRN·October 10, 2014