TPLC - Total Product Life Cycle

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Device	ventilator, continuous, minimal ventilatory support, facility use
Regulation Description	Continuous ventilator.
Product Code	MNT
Regulation Number	868.5895
Device Class	2

Premarket Reviews
Manufacturer	Decision
BREAS MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CRITICAL CARE AB
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN ORANGEMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K213521 Nihon Kohden NKV-330 Ventilator System

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3773	3773
Defective Component	1867	1867
Device Alarm System	1655	1655
Electrical /Electronic Property Problem	1592	1592
Therapeutic or Diagnostic Output Failure	1447	1447
Incorrect, Inadequate or Imprecise Result or Readings	1444	1444
Device Sensing Problem	1380	1380
Battery Problem	1264	1264
Defective Device	1148	1148
Unexpected Shutdown	938	938
Failure to Power Up	901	901
Power Problem	803	803
Output Problem	780	780
No Display/Image	704	704
Device Displays Incorrect Message	633	633
Gas/Air Leak	582	582
Defective Alarm	568	568
Mechanical Problem	554	554
Display or Visual Feedback Problem	536	536
Failure to Sense	515	515
Excessive Heating	482	482
Circuit Failure	400	400
Noise, Audible	319	319
Failure to Run on Battery	309	309
Break	307	307
Pressure Problem	295	295
Failure to Calibrate	294	294
Tidal Volume Fluctuations	288	288
Complete Loss of Power	287	287
Failure to Deliver	270	270
Failure to Charge	258	258
Protective Measures Problem	244	244
Display Difficult to Read	243	243
Failure to Shut Off	221	221
Unintended Power Up	197	197
Loss of Power	194	194
Self-Activation or Keying	191	191
Failure to Read Input Signal	189	189
Calibration Problem	179	179
No Flow	163	163
Computer Operating System Problem	162	162
Unstable	152	152
Infusion or Flow Problem	152	152
Insufficient Flow or Under Infusion	144	144
Appropriate Term/Code Not Available	139	139
Temperature Problem	139	139
Increase in Pressure	117	117
Poor Quality Image	116	116
Insufficient Information	115	115
Improper Flow or Infusion	115	115

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18234	18234
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	571	571
Hypoxia	106	106
Low Oxygen Saturation	94	94
Death	46	46
Dyspnea	30	30
Unspecified Respiratory Problem	18	18
Cardiac Arrest	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	9	9
Discomfort	7	7
Respiratory Failure	7	7
Bradycardia	6	6
Injury	6	6
No Information	6	6
Increased Respiratory Rate	5	5
Respiratory Distress	5	5
Respiratory Acidosis	4	4
Respiratory Insufficiency	3	3
Abnormal Blood Gases	3	3
No Code Available	3	3
Pressure Sores	3	3
Hypoventilation	3	3
Bacterial Infection	3	3
Fall	3	3
Pain	3	3
Aspiration Pneumonitis	3	3
Tachycardia	3	3
Pulmonary Emphysema	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Loss of consciousness	2	2
Chest Pain	2	2
Vomiting	2	2
Apnea	2	2
Fainting	2	2
Cardiopulmonary Arrest	2	2
Lethargy	2	2
Pneumonia	2	2
Asystole	2	2
Tissue Damage	2	2
Cyanosis	2	2
Unspecified Vascular Problem	1	1
Cancer	1	1
Infiltration into Tissue	1	1
Headache	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoxia in Utero	1	1