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
INTERNATIONAL BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
LINDE GAS & EQUIPMENT, INC.
	SUBSTANTIALLY EQUIVALENT	3
MALINCKRODT MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	1
MALLINCKRODT MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	4
PRAXAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Readings	226	226
Failure to Recalibrate	223	223
Intermittent Communication Failure	218	218
Failure to Deliver	135	135
Inaccurate Delivery	114	114
Gas Output Problem	52	52
Loose or Intermittent Connection	28	28
Calibration Problem	24	24
Gas/Air Leak	21	21
Device Sensing Problem	20	20
Therapeutic or Diagnostic Output Failure	19	19
Inappropriate or Unexpected Reset	18	18
Application Program Freezes, Becomes Nonfunctional	14	14
Device-Device Incompatibility	12	12
Failure to Calibrate	12	12
Output Problem	9	9
Device Alarm System	9	9
Defective Device	9	9
Device Displays Incorrect Message	8	8
Unexpected Shutdown	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Excess Flow or Over-Infusion	8	8
Break	7	7
Medical Gas Supply Problem	7	7
Communication or Transmission Problem	6	6
Insufficient Information	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Use of Device Problem	6	6
Improper Flow or Infusion	6	6
Defective Component	5	5
Infusion or Flow Problem	5	5
Protective Measures Problem	4	4
Low Readings	4	4
Battery Problem	4	4
Inaccurate Flow Rate	4	4
No Flow	3	3
Display or Visual Feedback Problem	3	3
Complete Loss of Power	3	3
Failure to Sense	3	3
Display Difficult to Read	3	3
Mechanical Problem	3	3
No Display/Image	3	3
Obstruction of Flow	2	2
Incorrect Measurement	2	2
Device Emits Odor	2	2
Incorrect Interpretation of Signal	2	2
Failure to Deliver Shock/Stimulation	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Charge	2	2
Fluid/Blood Leak	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	792	792
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	62	62
Insufficient Information	24	24
No Consequences Or Impact To Patient	13	13
Low Blood Pressure/ Hypotension	9	9
Bradycardia	6	6
Pulmonary Hypertension	5	5
Cardiac Arrest	5	5
Hypoxia	4	4
Unspecified Respiratory Problem	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tachycardia	3	3
High Pulmonary Arterial Wedge Pressure	2	2
Irritation	2	2
Dyspnea	2	2
Headache	2	2
Arrhythmia	1	1
Death	1	1
Pulmonary Dysfunction	1	1
Nausea	1	1
Malaise	1	1
Diminished Pulse Pressure	1	1
Chemical Exposure	1	1
Overdose	1	1
No Patient Involvement	1	1
Cardiomyopathy	1	1
Collapse	1	1
Underdose	1	1
Respiratory Distress Syndrome of Newborns	1	1
Loss of consciousness	1	1