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
1. K230173 Servo-air Lite Ventilator System
MEKICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN ORANGEMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3885	3885
Defective Component	1870	1870
Device Alarm System	1713	1713
Electrical /Electronic Property Problem	1674	1674
Incorrect, Inadequate or Imprecise Result or Readings	1447	1447
Therapeutic or Diagnostic Output Failure	1447	1447
Device Sensing Problem	1416	1416
Battery Problem	1264	1264
Defective Device	1148	1148
Unexpected Shutdown	967	967
Failure to Power Up	915	915
Power Problem	807	807
Output Problem	780	780
No Display/Image	731	731
Device Displays Incorrect Message	633	633
Gas/Air Leak	600	600
Failure to Sense	589	589
Mechanical Problem	582	582
Defective Alarm	570	570
Display or Visual Feedback Problem	538	538
Excessive Heating	493	493
Circuit Failure	406	406
Failure to Run on Battery	340	340
Complete Loss of Power	322	322
Noise, Audible	319	319
Tidal Volume Fluctuations	308	308
Break	307	307
Pressure Problem	296	296
Failure to Calibrate	294	294
Failure to Deliver	293	293
Failure to Charge	281	281
Display Difficult to Read	262	262
Protective Measures Problem	245	245
Failure to Shut Off	223	223
Unintended Power Up	209	209
Loss of Power	194	194
Unstable	193	193
Self-Activation or Keying	191	191
Failure to Read Input Signal	189	189
Calibration Problem	179	179
No Flow	165	165
Computer Operating System Problem	162	162
Infusion or Flow Problem	157	157
Insufficient Flow or Under Infusion	149	149
Temperature Problem	139	139
Appropriate Term/Code Not Available	139	139
Grounding Malfunction	130	130
Communication or Transmission Problem	121	121
Obstruction of Flow	121	121
Increase in Pressure	119	119

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19043	19043
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	576	576
Hypoxia	107	107
Low Oxygen Saturation	96	96
Death	46	46
Dyspnea	30	30
Unspecified Respiratory Problem	19	19
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
No Information	6	6
Injury	6	6
Increased Respiratory Rate	5	5
Respiratory Distress	5	5
Respiratory Acidosis	4	4
Tachycardia	3	3
Pain	3	3
Fall	3	3
Pressure Sores	3	3
Bacterial Infection	3	3
Respiratory Insufficiency	3	3
Abnormal Blood Gases	3	3
No Code Available	3	3
Hypoventilation	3	3
Aspiration Pneumonitis	3	3
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Loss of consciousness	2	2
Pulmonary Emphysema	2	2
Vomiting	2	2
Fainting	2	2
Chest Pain	2	2
Apnea	2	2
Cardiopulmonary Arrest	2	2
Asystole	2	2
Pneumonia	2	2
Tissue Damage	2	2
Lethargy	2	2
Cyanosis	2	2
Cancer	1	1
Unspecified Vascular Problem	1	1
Headache	1	1
Infiltration into Tissue	1	1
Low Blood Pressure/ Hypotension	1	1
Convulsion/Seizure	1	1