TPLC - Total Product Life Cycle

show TPLC since

Device	apparatus, nitric oxide delivery
Product Code	MRN
Regulation Number	868.5165
Device Class	2

Premarket Reviews
Manufacturer	Decision
AIRGAS THERAPEUTICS
	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	199	199
Failure to Recalibrate	196	196
Intermittent Communication Failure	185	185
Inaccurate Delivery	110	110
Failure to Deliver	104	104
Loose or Intermittent Connection	22	22
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
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Excess Flow or Over-Infusion	8	8
Break	7	7
Device Alarm System	7	7
Medical Gas Supply Problem	7	7
Unexpected Shutdown	6	6
Communication or Transmission Problem	6	6
Defective Component	5	5
Protective Measures Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Battery Problem	4	4
Infusion or Flow Problem	4	4
Use of Device Problem	4	4
Improper Flow or Infusion	4	4
Display or Visual Feedback Problem	3	3
Inaccurate Flow Rate	3	3
Noise, Audible	2	2
No Flow	2	2
Failure to Deliver Shock/Stimulation	2	2
Complete Loss of Power	2	2
Device Emits Odor	2	2
Gas/Air Leak	2	2
Failure to Sense	2	2
Insufficient Information	2	2
No Display/Image	2	2
Device-Device Incompatibility	2	2
Failure to Charge	2	2
Precipitate in Device or Device Ingredient	1	1
Unable to Obtain Readings	1	1
No Audible Alarm	1	1
Insufficient Flow or Under Infusion	1	1
Charging Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
False Alarm	1	1
Complete Blockage	1	1
Product Quality Problem	1	1
Failure to Auto Stop	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	610	610
No Known Impact Or Consequence To Patient	87	87
Low Oxygen Saturation	28	28
Insufficient Information	20	20
No Consequences Or Impact To Patient	13	13
Bradycardia	6	6
Low Blood Pressure/ Hypotension	5	5
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