Chapter 13 Medical Device Reporting (MDR)
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User Manual US
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Test Kit 300 (12-1830)
Contains: 1 Sensor* for 300 tests and 300 NIOX VERO
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Filters**
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Test Kit 500 (12-1850)
Contains: 1 Sensor* for 500 tests and 500 NIOX VERO
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Test Kit 1000 (12-1900)
Contains: 1 Sensor* for 1000 tests and 1000 NIOX VERO
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Filters**
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Sensor
Pre-calibrated disposable Sensor for 100, 300, 500 or 1000 measurements.
Operational life-time: Maximum 12 months when installed in NIOX VERO
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or
expiration date as stated on the Sensor, whichever comes first.
** NIOX VERO
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Filter
Disposable filter to be changed for each patient.
13 Medical Device Reporting (MDR)
Circassia, as a medical device manufacturer, must have a Medical Device
Reporting system in place to report to the FDA, any adverse events that have
occurred with its medical products.The purpose of the Medical Device Report-
ing system is to ensure the health and safety of patients, users and others us-
ing medical products by reducing the likelihood of the same type of adverse
event being repeated. This is achieved by immediate notification of experi-
enced incidents to enable corrective and preventive actions.
Specific guidelines, Medical Device Reporting system for user facilities, are
applicable for users of medical devices. An MDR reportable event is an event
about which a user facility becomes aware of information that reasonable sug-
gests that a device has or may have caused or contributed to a death or seri-
ous injury. Manufacturers of medical devices are obliged to report adverse
incidents to the FDA. Any user of Circassia's products, who experience an ad-
verse event related to the product, must therefore immediately report this to
Circassia Inc. The report should contain the following:
•
Description of the incident
•
When and where did the incident occur?
•
What product / accessory was involved, serial number/batch number?
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Was the incident related to instructions for use of the product?
•
Was the risk foreseeable and clinically acceptable in view of potential
patient benefit?
•
Was the outcome adversely affected by a patient's pre-existing condition?
•
Has the event been reported to the FDA? (only applicable if the use of the
device has or may have caused or contributed to injury or death)
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