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 , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CRITICAL CARE AB
	SUBSTANTIALLY EQUIVALENT	1
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	3685	3686
Electrical /Electronic Property Problem	1924	1925
Device Sensing Problem	1418	1418
Device Alarm System	1045	1057
Unexpected Shutdown	895	895
Battery Problem	769	769
Failure to Sense	743	743
Circuit Failure	681	681
Power Problem	676	688
Gas/Air Leak	587	587
Mechanical Problem	554	554
Failure to Power Up	535	535
Excessive Heating	516	516
No Display/Image	429	429
Complete Loss of Power	417	417
Failure to Run on Battery	399	399
Defective Alarm	342	342
Failure to Deliver	321	321
Tidal Volume Fluctuations	305	305
Display Difficult to Read	273	273
Unstable	236	236
Display or Visual Feedback Problem	224	224
Unintended Power Up	213	213
Defective Component	210	210
Failure to Charge	193	193
Pressure Problem	190	190
Grounding Malfunction	153	153
Insufficient Flow or Under Infusion	149	149
Communication or Transmission Problem	141	141
Obstruction of Flow	137	137
No Flow	128	128
Computer Software Problem	119	119
Noise, Audible	115	115
Increase in Pressure	103	103
Infusion or Flow Problem	102	102
Insufficient Information	100	100
Degraded	99	107
Failure to Shut Off	95	95
Volume Accuracy Problem	90	90
Therapeutic or Diagnostic Output Failure	84	96
Improper Flow or Infusion	77	77
Adverse Event Without Identified Device or Use Problem	58	58
Incorrect, Inadequate or Imprecise Result or Readings	57	57
Material Integrity Problem	55	55
Failure to Calibrate	52	52
Break	50	50
Mechanical Jam	49	49
Failure to Read Input Signal	49	49
No Audible Alarm	49	49
Gas Output Problem	48	48

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19406	19415
Insufficient Information	486	486
Hypoxia	107	107
Low Oxygen Saturation	72	72
Dyspnea	38	39
Unspecified Respiratory Problem	18	18
Cardiac Arrest	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	8	8
Respiratory Failure	7	7
Discomfort	6	18
Increased Respiratory Rate	5	5
Cyanosis	4	4
Death	4	4
No Patient Involvement	4	4
Aspiration Pneumonitis	3	3
Respiratory Insufficiency	3	3
Hypoventilation	3	3
Bacterial Infection	3	3
Abnormal Blood Gases	3	3
Bradycardia	3	3
Pain	3	3
Respiratory Acidosis	3	3
Lethargy	2	2
Loss of consciousness	2	2
Tachycardia	2	2
Asystole	2	2
Pneumonia	2	2
Fall	2	2
Chest Pain	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Apnea	2	2
Pulmonary Emphysema	2	2
Wheezing	2	2
Encephalopathy	1	1
High Blood Pressure/ Hypertension	1	1
Ventilator Dependent	1	1
Hypoxia in Utero	1	1
Low Blood Pressure/ Hypotension	1	1
Impaired Healing	1	1
Sleep Dysfunction	1	1
Unspecified Vascular Problem	1	1
Cancer	1	1
No Consequences Or Impact To Patient	1	1
Infiltration into Tissue	1	1
Headache	1	1
Pneumothorax	1	1
Sweating	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1