TPLC - Total Product Life Cycle

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Device	apparatus, nitric oxide delivery
Regulation Description	Nitric oxide administration apparatus.
Product Code	MRN
Regulation Number	868.5165
Device Class	2

Premarket Reviews
Manufacturer	Decision
AIRGAS THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
AIRGAS THERAPEUTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
LINDE GAS & EQUIPMENT, INC.
	SUBSTANTIALLY EQUIVALENT	3
MALINCKRODT MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	1
MALLINCKRODT MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Readings	214	214
Intermittent Communication Failure	212	212
Failure to Recalibrate	212	212
Failure to Deliver	89	89
Inaccurate Delivery	78	78
Gas Output Problem	45	45
Loose or Intermittent Connection	26	26
Inappropriate or Unexpected Reset	18	18
Gas/Air Leak	16	16
Application Program Freezes, Becomes Nonfunctional	14	14
Device-Device Incompatibility	11	11
Unexpected Shutdown	8	8
Insufficient Information	6	6
Therapeutic or Diagnostic Output Failure	5	5
Battery Problem	4	4
Use of Device Problem	4	4
Improper Flow or Infusion	4	4
Low Readings	4	4
No Display/Image	3	3
Mechanical Problem	3	3
Complete Loss of Power	3	3
Defective Component	3	3
Device Sensing Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Device Displays Incorrect Message	2	2
Improper or Incorrect Procedure or Method	2	2
Incorrect Interpretation of Signal	2	2
Incorrect Measurement	2	2
Calibration Problem	2	2
Infusion or Flow Problem	2	2
Display Difficult to Read	2	2
Device Alarm System	2	2
Failure to Charge	2	2
Inaccurate Flow Rate	1	1
False Alarm	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Obstruction of Flow	1	1
Component Missing	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Precipitate in Device or Device Ingredient	1	1
Imprecision	1	1
Failure to Calibrate	1	1
Power Problem	1	1
Protective Measures Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Application Program Problem	1	1
Undercorrection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	697	697
Low Oxygen Saturation	48	48
Insufficient Information	15	15
Low Blood Pressure/ Hypotension	9	9
Pulmonary Hypertension	5	5
Cardiac Arrest	5	5
Hypoxia	4	4
Bradycardia	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Tachycardia	2	2
Death	1	1
Arrhythmia	1	1
Pulmonary Dysfunction	1	1
Malaise	1	1
Diminished Pulse Pressure	1	1
Dyspnea	1	1
Cardiomyopathy	1	1
Underdose	1	1
Unspecified Respiratory Problem	1	1
No Consequences Or Impact To Patient	1	1
Respiratory Distress Syndrome of Newborns	1	1