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	229	229
Failure to Recalibrate	227	227
Intermittent Communication Failure	219	219
Inaccurate Delivery	108	108
Failure to Deliver	94	94
Gas Output Problem	59	59
Loose or Intermittent Connection	28	28
Gas/Air Leak	26	26
Inappropriate or Unexpected Reset	19	19
Application Program Freezes or Fails to Launch	15	15
Device-Device Incompatibility	13	13
Device Sensing Problem	7	7
Unexpected Shutdown	6	6
Insufficient Device Problem Information	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Use of Device Problem	5	5
Battery Problem	4	4
Low Readings	4	4
Complete Loss of Power	3	3
Display Difficult to Read	3	3
Improper Flow or Infusion	3	3
Improper or Incorrect Procedure or Method	2	2
Incorrect Interpretation of Signal	2	2
Incorrect Measurement	2	2
Defective Component	2	2
Communication or Transmission Problem	2	2
Mechanical Problem	2	2
No Display/Image	2	2
Failure to Charge	2	2
False Alarm	1	1
Device Handling Problem	1	1
Excess Flow or Over-Infusion	1	1
Obstruction of Flow	1	1
Imprecision	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Failure to Calibrate	1	1
Power Problem	1	1
Undercorrection	1	1
Circuit Failure	1	1
Signal Artifact/Noise	1	1
Premature Discharge of Battery	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	819	819
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
Pulmonary Hypertension	5	5
Cardiac Arrest	5	5
Hypoxia	4	4
Unspecified Respiratory Problem	4	4
Tachycardia	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
High Pulmonary Arterial Wedge Pressure	2	2
Irritation	2	2
Dyspnea	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
Facial Paralysis	1	1