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	219	219
Failure to Recalibrate	217	217
Intermittent Communication Failure	214	214
Failure to Deliver	94	94
Inaccurate Delivery	79	79
Gas Output Problem	59	59
Loose or Intermittent Connection	28	28
Gas/Air Leak	26	26
Inappropriate or Unexpected Reset	19	19
Application Program Freezes or Fails to Launch	15	15
Device-Device Incompatibility	13	13
Device Sensing Problem	7	7
Unexpected Shutdown	6	6
Insufficient Device Problem Information	6	6
Battery Problem	4	4
Low Readings	4	4
Display Difficult to Read	3	3
Complete Loss of Power	3	3
Use of Device Problem	3	3
Improper Flow or Infusion	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Incorrect Interpretation of Signal	2	2
Incorrect Measurement	2	2
Defective Component	2	2
Mechanical Problem	2	2
No Display/Image	2	2
Failure to Charge	2	2
Device Handling Problem	1	1
False Alarm	1	1
Excess Flow or Over-Infusion	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Obstruction of Flow	1	1
Failure to Calibrate	1	1
Power Problem	1	1
Imprecision	1	1
Undercorrection	1	1
Circuit Failure	1	1
Signal Artifact/Noise	1	1
Premature Discharge of Battery	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	743	743
Low Oxygen Saturation	54	54
Insufficient Information	15	15
Low Blood Pressure/ Hypotension	11	11
Pulmonary Hypertension	5	5
Cardiac Arrest	5	5
Hypoxia	4	4
Bradycardia	3	3
Unspecified Respiratory Problem	3	3
High Pulmonary Arterial Wedge Pressure	2	2
Tachycardia	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Arrhythmia	1	1
Death	1	1
Pulmonary Dysfunction	1	1
Malaise	1	1
Diminished Pulse Pressure	1	1
Dyspnea	1	1
Cardiomyopathy	1	1
Underdose	1	1
Respiratory Distress Syndrome of Newborns	1	1
No Consequences Or Impact To Patient	1	1
Facial Paralysis	1	1