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
1. K242931 HFT750U
NIHON KOHDEN ORANGEMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3937	3938
Electrical /Electronic Property Problem	2596	2597
Device Sensing Problem	1514	1514
Device Alarm System	1379	1391
Circuit Failure	1271	1271
Unexpected Shutdown	1028	1028
Battery Problem	1014	1014
Degraded	863	871
Failure to Sense	840	840
Defective Component	821	821
Failure to Power Up	747	747
Power Problem	743	755
Mechanical Problem	668	668
Gas/Air Leak	667	667
No Display/Image	600	600
Excessive Heating	545	545
Defective Alarm	501	501
Complete Loss of Power	478	478
Failure to Run on Battery	453	453
Therapeutic or Diagnostic Output Failure	439	451
Tidal Volume Fluctuations	369	369
Failure to Deliver	363	363
Device Displays Incorrect Message	324	336
Failure to Charge	302	302
Display Difficult to Read	296	296
Unstable	276	276
Display or Visual Feedback Problem	273	273
Defective Device	245	245
Unintended Power Up	226	226
Pressure Problem	219	219
Noise, Audible	215	215
Grounding Malfunction	206	206
Incorrect, Inadequate or Imprecise Result or Readings	177	177
Failure to Shut Off	167	167
Insufficient Flow or Under Infusion	158	158
Obstruction of Flow	157	157
Communication or Transmission Problem	151	151
Failure to Calibrate	151	151
No Flow	142	142
Output Problem	139	139
Break	137	137
Computer Software Problem	131	131
Infusion or Flow Problem	122	122
Increase in Pressure	118	118
Failure to Read Input Signal	115	115
Insufficient Information	112	112
No Audible Alarm	109	109
Self-Activation or Keying	102	102
Volume Accuracy Problem	96	96
Adverse Event Without Identified Device or Use Problem	93	93

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23155	23164
No Patient Involvement	1499	1499
No Known Impact Or Consequence To Patient	713	713
Insufficient Information	597	597
No Consequences Or Impact To Patient	390	390
Hypoxia	116	116
Low Oxygen Saturation	108	108
Dyspnea	46	47
Death	29	29
Unspecified Respiratory Problem	21	21
Cardiac Arrest	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Respiratory Arrest	9	9
Bradycardia	7	7
Respiratory Failure	7	7
Discomfort	7	19
Injury	6	6
Cyanosis	5	5
Increased Respiratory Rate	5	5
Respiratory Distress	4	4
Aspiration Pneumonitis	3	3
Anxiety	3	3
Tachycardia	3	3
Hypoventilation	3	3
Abnormal Blood Gases	3	3
No Information	3	3
Pain	3	3
Bacterial Infection	3	3
Respiratory Insufficiency	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Respiratory Acidosis	3	3
Unspecified Tissue Injury	2	2
Asystole	2	2
Pneumonia	2	2
Tissue Damage	2	2
Fall	2	2
Cardiopulmonary Arrest	2	2
Fainting	2	2
Chest Pain	2	2
Loss of consciousness	2	2
Angina	2	2
Pulmonary Emphysema	2	2
Wheezing	2	2
Pneumothorax	2	2
Apnea	2	2
Lethargy	2	2
Headache	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1
Therapeutic Response, Decreased	1	1