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	209	209
Failure to Recalibrate	206	206
Intermittent Communication Failure	195	195
Inaccurate Delivery	111	111
Failure to Deliver	111	111
Loose or Intermittent Connection	24	24
Calibration Problem	22	22
Therapeutic or Diagnostic Output Failure	18	18
Device Sensing Problem	15	15
Failure to Calibrate	11	11
Output Problem	9	9
Defective Device	9	9
Device Displays Incorrect Message	8	8
Excess Flow or Over-Infusion	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Device Alarm System	7	7
Break	7	7
Medical Gas Supply Problem	7	7
Communication or Transmission Problem	6	6
Unexpected Shutdown	6	6
Defective Component	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Battery Problem	4	4
Use of Device Problem	4	4
Improper Flow or Infusion	4	4
Infusion or Flow Problem	4	4
Inappropriate or Unexpected Reset	4	4
Protective Measures Problem	4	4
Insufficient Information	3	3
Inaccurate Flow Rate	3	3
Display or Visual Feedback Problem	3	3
Noise, Audible	2	2
Failure to Sense	2	2
Failure to Charge	2	2
No Display/Image	2	2
No Flow	2	2
Device-Device Incompatibility	2	2
Gas/Air Leak	2	2
Failure to Deliver Shock/Stimulation	2	2
Complete Loss of Power	2	2
Device Emits Odor	2	2
Fluid/Blood Leak	1	1
Improper or Incorrect Procedure or Method	1	1
Gas Output Problem	1	1
Premature Discharge of Battery	1	1
Appropriate Term/Code Not Available	1	1
Signal Artifact/Noise	1	1
Circuit Failure	1	1
Low Readings	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	643	643
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	28	28
Insufficient Information	21	21
No Consequences Or Impact To Patient	13	13
Bradycardia	6	6
Low Blood Pressure/ Hypotension	6	6
Hypoxia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tachycardia	3	3
High Pulmonary Arterial Wedge Pressure	2	2
Cardiac Arrest	2	2
Irritation	2	2
Dyspnea	2	2
Headache	2	2
Pulmonary Hypertension	1	1
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
Collapse	1	1
Underdose	1	1
Unspecified Respiratory Problem	1	1
Loss of consciousness	1	1