TPLC - Total Product Life Cycle

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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
MEKICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN ORANGEMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K213521 Nihon Kohden NKV-330 Ventilator System
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3918	3919
Electrical /Electronic Property Problem	2853	2854
Circuit Failure	1531	1531
Device Sensing Problem	1486	1486
Device Alarm System	1091	1091
Unexpected Shutdown	919	919
Degraded	900	908
Failure to Sense	859	859
Battery Problem	721	721
Power Problem	672	672
Gas/Air Leak	622	622
Mechanical Problem	600	600
Excessive Heating	546	546
Failure to Power Up	505	505
Complete Loss of Power	499	499
Failure to Run on Battery	468	468
No Display/Image	423	423
Failure to Deliver	363	363
Tidal Volume Fluctuations	349	349
Display Difficult to Read	302	302
Unstable	297	297
Defective Alarm	295	295
Unintended Power Up	229	229
Grounding Malfunction	216	216
Failure to Charge	216	216
Display or Visual Feedback Problem	215	215
Pressure Problem	184	184
Communication or Transmission Problem	151	151
Insufficient Flow or Under Infusion	151	151
Obstruction of Flow	145	145
Computer Software Problem	132	132
No Audible Alarm	131	131
No Flow	116	116
Insufficient Device Problem Information	111	111
Infusion or Flow Problem	106	106
Increase in Pressure	100	100
Failure to Shut Off	93	93
Volume Accuracy Problem	90	90
Noise, Audible	87	87
Improper Flow or Infusion	84	84
Adverse Event Without Identified Device or Use Problem	74	74
Material Integrity Problem	58	58
Gas Output Problem	48	48
Mechanical Jam	48	48
Decrease in Pressure	43	43
Audible Prompt/Feedback Problem	43	43
Contamination	40	40
Intermittent Loss of Power	39	39
Erratic or Intermittent Display	37	37
Failure to Calibrate	35	35

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23934	23943
No Patient Involvement	1499	1499
No Known Impact Or Consequence To Patient	713	713
Insufficient Information	598	598
No Consequences Or Impact To Patient	390	390
Hypoxia	116	116
Low Oxygen Saturation	111	111
Dyspnea	48	49
Death	29	29
Unspecified Respiratory Problem	21	21
Cardiac Arrest	13	13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Respiratory Failure	9	9
Respiratory Arrest	9	9
Bradycardia	7	7
Discomfort	7	19
Injury	6	6
Cyanosis	5	5
Increased Respiratory Rate	5	5
Respiratory Distress	4	4
Aspiration Pneumonitis	3	3
Respiratory Insufficiency	3	3
Hypoventilation	3	3
Bacterial Infection	3	3
Abnormal Blood Gases	3	3
No Information	3	3
Anxiety	3	3
Tachycardia	3	3
Pain	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Respiratory Acidosis	3	3
Lethargy	2	2
Loss of consciousness	2	2
Fainting	2	2
Tissue Damage	2	2
Unspecified Tissue Injury	2	2
Asystole	2	2
Pneumonia	2	2
Fall	2	2
Cardiopulmonary Arrest	2	2
Chest Pain	2	2
Angina	2	2
Apnea	2	2
Pneumothorax	2	2
Wheezing	2	2
Pulmonary Emphysema	2	2
Aspiration/Inhalation	2	2
Altered State of Consciousness	1	1
Distress	1	1
Bruise/Contusion	1	1