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	220	220
Failure to Recalibrate	217	217
Intermittent Communication Failure	212	212
Failure to Deliver	126	126
Inaccurate Delivery	113	113
Loose or Intermittent Connection	27	27
Calibration Problem	24	24
Therapeutic or Diagnostic Output Failure	19	19
Gas Output Problem	15	15
Device Sensing Problem	15	15
Inappropriate or Unexpected Reset	14	14
Failure to Calibrate	12	12
Gas/Air Leak	11	11
Application Program Freezes, Becomes Nonfunctional	10	10
Output Problem	9	9
Device Alarm System	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
Unexpected Shutdown	7	7
Break	7	7
Medical Gas Supply Problem	7	7
Communication or Transmission Problem	6	6
Insufficient Information	6	6
Use of Device Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Defective Component	5	5
Improper Flow or Infusion	5	5
Device-Device Incompatibility	4	4
Protective Measures Problem	4	4
Low Readings	4	4
Battery Problem	4	4
Infusion or Flow Problem	4	4
Inaccurate Flow Rate	4	4
Display or Visual Feedback Problem	3	3
Complete Loss of Power	3	3
No Display/Image	3	3
Device Emits Odor	2	2
Failure to Sense	2	2
Mechanical Problem	2	2
Failure to Deliver Shock/Stimulation	2	2
Improper or Incorrect Procedure or Method	2	2
No Flow	2	2
Failure to Charge	2	2
Fluid/Blood Leak	2	2
Noise, Audible	2	2
Obstruction of Flow	1	1
Component Missing	1	1
Precipitate in Device or Device Ingredient	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	719	719
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	47	47
Insufficient Information	24	24
No Consequences Or Impact To Patient	13	13
Low Blood Pressure/ Hypotension	8	8
Bradycardia	6	6
Hypoxia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cardiac Arrest	3	3
Tachycardia	3	3
Pulmonary Hypertension	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Irritation	2	2
Dyspnea	2	2
Unspecified Respiratory Problem	2	2
Headache	2	2
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
Underdose	1	1
Loss of consciousness	1	1
Respiratory Distress Syndrome of Newborns	1	1