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	228	228
Failure to Recalibrate	226	226
Intermittent Communication Failure	218	218
Inaccurate Delivery	108	108
Failure to Deliver	93	93
Gas Output Problem	55	55
Loose or Intermittent Connection	28	28
Gas/Air Leak	21	21
Inappropriate or Unexpected Reset	19	19
Application Program Freezes or Fails to Launch	15	15
Device-Device Incompatibility	13	13
Insufficient Device Problem Information	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Device Sensing Problem	6	6
Use of Device Problem	5	5
Unexpected Shutdown	5	5
Low Readings	4	4
Battery Problem	4	4
Display Difficult to Read	3	3
Complete Loss of Power	3	3
Improper Flow or Infusion	3	3
Defective Component	2	2
Improper or Incorrect Procedure or Method	2	2
Communication or Transmission Problem	2	2
Incorrect Interpretation of Signal	2	2
Mechanical Problem	2	2
Incorrect Measurement	2	2
No Display/Image	2	2
Failure to Charge	2	2
Device Contamination with Chemical or Other Material	1	1
No Flow	1	1
Detachment of Device or Device Component	1	1
Power Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Device Handling Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Imprecision	1	1
Circuit Failure	1	1
Obstruction of Flow	1	1
Failure to Calibrate	1	1
Premature Discharge of Battery	1	1
Signal Artifact/Noise	1	1
False Alarm	1	1
Undercorrection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	804	804
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	65	65
Insufficient Information	24	24
No Consequences Or Impact To Patient	13	13
Low Blood Pressure/ Hypotension	11	11
Bradycardia	6	6
Cardiac Arrest	5	5
Pulmonary Hypertension	5	5
Unspecified Respiratory Problem	4	4
Hypoxia	4	4
Tachycardia	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Headache	2	2
Dyspnea	2	2
High Pulmonary Arterial Wedge Pressure	2	2
Irritation	2	2
Cardiomyopathy	1	1
Overdose	1	1
Underdose	1	1
Collapse	1	1
Death	1	1
Loss of consciousness	1	1
No Patient Involvement	1	1
Malaise	1	1
Facial Paralysis	1	1
Nausea	1	1
Respiratory Distress Syndrome of Newborns	1	1
Pulmonary Dysfunction	1	1
Chemical Exposure	1	1
Diminished Pulse Pressure	1	1
Arrhythmia	1	1