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	3692	3693
Electrical /Electronic Property Problem	1787	1787
Device Sensing Problem	1433	1433
Device Alarm System	1289	1301
Battery Problem	1007	1007
Unexpected Shutdown	970	970
Defective Component	820	820
Power Problem	739	751
Failure to Power Up	720	720
Failure to Sense	692	692
Gas/Air Leak	619	619
Mechanical Problem	607	607
No Display/Image	552	552
Circuit Failure	543	543
Excessive Heating	510	510
Defective Alarm	499	499
Therapeutic or Diagnostic Output Failure	439	451
Failure to Run on Battery	388	388
Complete Loss of Power	385	385
Device Displays Incorrect Message	324	336
Failure to Deliver	317	317
Tidal Volume Fluctuations	310	310
Display Difficult to Read	267	267
Failure to Charge	265	265
Display or Visual Feedback Problem	264	264
Defective Device	245	245
Unstable	228	228
Unintended Power Up	220	220
Pressure Problem	215	215
Noise, Audible	214	214
Incorrect, Inadequate or Imprecise Result or Readings	171	171
Failure to Shut Off	160	160
Failure to Calibrate	151	151
Grounding Malfunction	148	148
Insufficient Flow or Under Infusion	147	147
No Flow	142	142
Communication or Transmission Problem	138	138
Output Problem	138	138
Break	137	137
Obstruction of Flow	132	132
Infusion or Flow Problem	117	117
Computer Software Problem	117	117
Failure to Read Input Signal	115	115
Increase in Pressure	113	113
Insufficient Information	103	103
Self-Activation or Keying	102	102
Volume Accuracy Problem	96	96
Temperature Problem	89	89
Improper Flow or Infusion	87	87
Protective Measures Problem	84	84

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20143	20144
No Patient Involvement	1499	1499
No Known Impact Or Consequence To Patient	713	713
Insufficient Information	579	579
No Consequences Or Impact To Patient	390	390
Hypoxia	110	110
Low Oxygen Saturation	94	94
Dyspnea	32	32
Death	29	29
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	19
Bradycardia	6	6
Respiratory Failure	6	6
Injury	6	6
Increased Respiratory Rate	5	5
Respiratory Distress	4	4
Tachycardia	3	3
Aspiration Pneumonitis	3	3
Hypoventilation	3	3
Pain	3	3
Abnormal Blood Gases	3	3
No Information	3	3
Bacterial Infection	3	3
Respiratory Insufficiency	3	3
Respiratory Acidosis	3	3
Asystole	2	2
Pneumonia	2	2
Tissue Damage	2	2
Fall	2	2
Cardiopulmonary Arrest	2	2
Chest Pain	2	2
Fainting	2	2
Loss of consciousness	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Pulmonary Emphysema	2	2
Aspiration/Inhalation	2	2
Wheezing	2	2
Apnea	2	2
Lethargy	2	2
Cyanosis	2	2
Headache	1	1
Infiltration into Tissue	1	1
Pressure Sores	1	1
Cancer	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1
Therapeutic Response, Decreased	1	1