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	3900	3901
Electrical /Electronic Property Problem	2736	2737
Device Sensing Problem	1474	1474
Circuit Failure	1428	1428
Device Alarm System	1081	1081
Unexpected Shutdown	912	912
Degraded	886	894
Failure to Sense	850	850
Battery Problem	720	720
Power Problem	670	670
Gas/Air Leak	614	614
Mechanical Problem	592	592
Excessive Heating	541	541
Failure to Power Up	503	503
Complete Loss of Power	485	485
Failure to Run on Battery	459	459
No Display/Image	421	421
Failure to Deliver	356	356
Tidal Volume Fluctuations	338	338
Display Difficult to Read	297	297
Defective Alarm	295	295
Unstable	288	288
Unintended Power Up	220	220
Failure to Charge	215	215
Display or Visual Feedback Problem	213	213
Grounding Malfunction	212	212
Pressure Problem	184	184
Communication or Transmission Problem	149	149
Insufficient Flow or Under Infusion	148	148
Obstruction of Flow	144	144
Computer Software Problem	127	127
No Audible Alarm	118	118
No Flow	116	116
Insufficient Device Problem Information	110	110
Infusion or Flow Problem	106	106
Increase in Pressure	98	98
Failure to Shut Off	93	93
Volume Accuracy Problem	90	90
Noise, Audible	87	87
Improper Flow or Infusion	83	83
Adverse Event Without Identified Device or Use Problem	74	74
Material Integrity Problem	58	58
Mechanical Jam	48	48
Gas Output Problem	48	48
Audible Prompt/Feedback Problem	43	43
Decrease in Pressure	42	42
Intermittent Loss of Power	39	39
Erratic or Intermittent Display	37	37
Contamination	36	36
No Audible Prompt/Feedback	35	35

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23593	23602
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	598	598
Hypoxia	116	116
Low Oxygen Saturation	116	116
Dyspnea	49	50
Death	46	46
Unspecified Respiratory Problem	21	21
Cardiac Arrest	13	13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Respiratory Arrest	9	9
Respiratory Failure	8	8
Bradycardia	7	7
Discomfort	7	19
No Information	6	6
Injury	6	6
Respiratory Distress	5	5
Increased Respiratory Rate	5	5
Cyanosis	5	5
Respiratory Acidosis	4	4
Anxiety	3	3
Pressure Sore/Ulcer	3	3
Abnormal Blood Gases	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Tachycardia	3	3
Pain	3	3
No Code Available	3	3
Hypoventilation	3	3
Aspiration Pneumonitis	3	3
Bacterial Infection	3	3
Fall	3	3
Respiratory Insufficiency	3	3
Lethargy	2	2
Pneumonia	2	2
Pulmonary Emphysema	2	2
Loss of consciousness	2	2
Angina	2	2
Cardiopulmonary Arrest	2	2
Unspecified Tissue Injury	2	2
Apnea	2	2
Wheezing	2	2
Chest Pain	2	2
Tissue Damage	2	2
Fainting	2	2
Aspiration/Inhalation	2	2
Vomiting	2	2
Asystole	2	2
Pneumothorax	2	2