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
1. K240410 EVOLVE Nitric Oxide Delivery System
MALLINCKRODT MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	4
PRAXAIR, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Readings	214	214
Failure to Recalibrate	211	211
Intermittent Communication Failure	203	203
Failure to Deliver	118	118
Inaccurate Delivery	112	112
Loose or Intermittent Connection	26	26
Calibration Problem	22	22
Therapeutic or Diagnostic Output Failure	18	18
Device Sensing Problem	15	15
Failure to Calibrate	12	12
Output Problem	9	9
Defective Device	9	9
Device Displays Incorrect Message	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
Device Alarm System	7	7
Unexpected Shutdown	6	6
Inappropriate or Unexpected Reset	6	6
Communication or Transmission Problem	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Defective Component	5	5
Use of Device Problem	5	5
Protective Measures Problem	4	4
Infusion or Flow Problem	4	4
Battery Problem	4	4
Improper Flow or Infusion	4	4
Display or Visual Feedback Problem	3	3
Complete Loss of Power	3	3
Low Readings	3	3
Inaccurate Flow Rate	3	3
Gas/Air Leak	3	3
Insufficient Information	3	3
Failure to Sense	2	2
Device Emits Odor	2	2
No Display/Image	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Failure to Deliver Shock/Stimulation	2	2
Device-Device Incompatibility	2	2
No Flow	2	2
Failure to Charge	2	2
Fluid/Blood Leak	2	2
Noise, Audible	2	2
Precipitate in Device or Device Ingredient	1	1
Unable to Obtain Readings	1	1
No Audible Alarm	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Insufficient Flow or Under Infusion	1	1
Charging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	670	670
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	33	33
Insufficient Information	21	21
No Consequences Or Impact To Patient	13	13
Low Blood Pressure/ Hypotension	7	7
Bradycardia	6	6
Hypoxia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tachycardia	3	3
High Pulmonary Arterial Wedge Pressure	2	2
Cardiac Arrest	2	2
Irritation	2	2
Dyspnea	2	2
Headache	2	2
Pulmonary Hypertension	1	1
Death	1	1
Arrhythmia	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
Collapse	1	1
Cardiomyopathy	1	1
Unspecified Respiratory Problem	1	1
Underdose	1	1
Loss of consciousness	1	1
Respiratory Distress Syndrome of Newborns	1	1