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
1. K201339 The NOxBOXi Nitric Oxide Delivery System

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Readings	225	225
Failure to Recalibrate	222	222
Intermittent Communication Failure	217	217
Failure to Deliver	131	131
Inaccurate Delivery	113	113
Gas Output Problem	46	46
Loose or Intermittent Connection	27	27
Calibration Problem	24	24
Therapeutic or Diagnostic Output Failure	19	19
Inappropriate or Unexpected Reset	18	18
Device Sensing Problem	18	18
Gas/Air Leak	17	17
Application Program Freezes, Becomes Nonfunctional	14	14
Failure to Calibrate	12	12
Device-Device Incompatibility	11	11
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
Display or Visual Feedback Problem	3	3
Complete Loss of Power	3	3
No Display/Image	3	3
Mechanical Problem	3	3
Noise, Audible	2	2
Fluid/Blood Leak	2	2
Failure to Charge	2	2
No Flow	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Deliver Shock/Stimulation	2	2
Incorrect Measurement	2	2
Device Emits Odor	2	2
Failure to Sense	2	2
Incorrect Interpretation of Signal	2	2
Display Difficult to Read	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	773	773
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	59	59
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
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
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