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
1. K220898 NOxBOXi Nitric Oxide Delivery System
2. K231823 NOxBOXi Nitric Oxide Delivery System
3. K233251 NOxBOXi Nitric Oxide Delivery System
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	222	222
Failure to Recalibrate	219	219
Intermittent Communication Failure	212	212
Failure to Deliver	126	126
Inaccurate Delivery	113	113
Loose or Intermittent Connection	27	27
Calibration Problem	24	24
Gas Output Problem	22	22
Therapeutic or Diagnostic Output Failure	19	19
Device Sensing Problem	17	17
Inappropriate or Unexpected Reset	15	15
Gas/Air Leak	13	13
Failure to Calibrate	12	12
Application Program Freezes, Becomes Nonfunctional	11	11
Output Problem	9	9
Device Alarm System	9	9
Defective Device	9	9
Device-Device Incompatibility	8	8
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
Adverse Event Without Identified Device or Use Problem	6	6
Use of Device Problem	6	6
Defective Component	5	5
Improper Flow or Infusion	5	5
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
Display Difficult to Read	2	2
Incorrect Interpretation of Signal	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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	729	729
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	55	55
Insufficient Information	24	24
No Consequences Or Impact To Patient	13	13
Low Blood Pressure/ Hypotension	8	8
Bradycardia	6	6
Pulmonary Hypertension	4	4
Hypoxia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cardiac Arrest	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
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