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
1. K212409 Ulspira TS Nitric Oxide Therapy System
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	219	219
Failure to Recalibrate	216	216
Intermittent Communication Failure	212	212
Failure to Deliver	125	125
Inaccurate Delivery	113	113
Loose or Intermittent Connection	27	27
Calibration Problem	24	24
Therapeutic or Diagnostic Output Failure	19	19
Device Sensing Problem	15	15
Inappropriate or Unexpected Reset	12	12
Failure to Calibrate	12	12
Output Problem	9	9
Device Alarm System	9	9
Defective Device	9	9
Gas/Air Leak	9	9
Device Displays Incorrect Message	8	8
Application Program Freezes, Becomes Nonfunctional	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Excess Flow or Over-Infusion	8	8
Gas Output Problem	7	7
Unexpected Shutdown	7	7
Break	7	7
Medical Gas Supply Problem	7	7
Communication or Transmission Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Use of Device Problem	6	6
Insufficient Information	5	5
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
Device-Device Incompatibility	3	3
Device Emits Odor	2	2
Failure to Sense	2	2
Mechanical Problem	2	2
No Display/Image	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	712	712
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	39	39
Insufficient Information	23	23
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
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
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