TPLC - Total Product Life Cycle

show TPLC since

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
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	213	213
Failure to Recalibrate	210	210
Intermittent Communication Failure	201	201
Failure to Deliver	117	117
Inaccurate Delivery	111	111
Loose or Intermittent Connection	25	25
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
Medical Gas Supply Problem	7	7
Device Alarm System	7	7
Break	7	7
Unexpected Shutdown	6	6
Inappropriate or Unexpected Reset	6	6
Communication or Transmission Problem	6	6
Defective Component	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Protective Measures Problem	4	4
Infusion or Flow Problem	4	4
Battery Problem	4	4
Use of Device Problem	4	4
Improper Flow or Infusion	4	4
Display or Visual Feedback Problem	3	3
Complete Loss of Power	3	3
Low Readings	3	3
Inaccurate Flow Rate	3	3
Gas/Air Leak	3	3
Insufficient Information	3	3
No Display/Image	2	2
Device Emits Odor	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Failure to Sense	2	2
Failure to Deliver Shock/Stimulation	2	2
Device-Device Incompatibility	2	2
No Flow	2	2
Failure to Charge	2	2
Noise, Audible	2	2
Precipitate in Device or Device Ingredient	1	1
Unable to Obtain Readings	1	1
No Audible Alarm	1	1
Mechanical Problem	1	1
Insufficient Flow or Under Infusion	1	1
Charging Problem	1	1
Off-Label Use	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	662	662
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	32	32
Insufficient Information	21	21
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
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