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
1. K240779 Vivo 3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3674	3674
Defective Component	1867	1867
Device Alarm System	1631	1631
Electrical /Electronic Property Problem	1526	1526
Therapeutic or Diagnostic Output Failure	1447	1447
Incorrect, Inadequate or Imprecise Result or Readings	1443	1443
Device Sensing Problem	1342	1342
Battery Problem	1264	1264
Defective Device	1148	1148
Unexpected Shutdown	925	925
Failure to Power Up	890	890
Power Problem	801	801
Output Problem	779	779
No Display/Image	687	687
Device Displays Incorrect Message	633	633
Gas/Air Leak	567	567
Defective Alarm	563	563
Display or Visual Feedback Problem	533	533
Mechanical Problem	523	523
Excessive Heating	473	473
Failure to Sense	459	459
Noise, Audible	319	319
Break	307	307
Circuit Failure	305	305
Failure to Calibrate	294	294
Pressure Problem	291	291
Failure to Run on Battery	289	289
Tidal Volume Fluctuations	278	278
Complete Loss of Power	272	272
Failure to Deliver	256	256
Failure to Charge	245	245
Protective Measures Problem	243	243
Display Difficult to Read	229	229
Failure to Shut Off	220	220
Loss of Power	194	194
Unintended Power Up	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
Infusion or Flow Problem	152	152
Insufficient Flow or Under Infusion	142	142
Appropriate Term/Code Not Available	139	139
Temperature Problem	139	139
Unstable	121	121
Poor Quality Image	116	116
Improper Flow or Infusion	115	115
Increase in Pressure	113	113
Insufficient Information	113	113

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	17587	17587
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	568	568
Hypoxia	105	105
Low Oxygen Saturation	94	94
Death	46	46
Dyspnea	30	30
Unspecified Respiratory Problem	17	17
Cardiac Arrest	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	8	8
Respiratory Failure	7	7
Discomfort	6	6
Bradycardia	6	6
Injury	6	6
No Information	6	6
Respiratory Distress	5	5
Increased Respiratory Rate	5	5
Pressure Sores	3	3
Fall	3	3
Tachycardia	3	3
Bacterial Infection	3	3
Aspiration Pneumonitis	3	3
Respiratory Acidosis	3	3
Pain	3	3
Abnormal Blood Gases	3	3
Respiratory Insufficiency	3	3
No Code Available	3	3
Fainting	2	2
Cyanosis	2	2
Pneumonia	2	2
Apnea	2	2
Lethargy	2	2
Pulmonary Emphysema	2	2
Chest Pain	2	2
Asystole	2	2
Cardiopulmonary Arrest	2	2
Hypoventilation	2	2
Vomiting	2	2
Tissue Damage	2	2
Loss of consciousness	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
High Blood Pressure/ Hypertension	1	1
Convulsion/Seizure	1	1
Ventilator Dependent	1	1
Urinary Retention	1	1
Encephalopathy	1	1
Low Blood Pressure/ Hypotension	1	1