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
1. K191624 F&P Nivairo RT047 Vented Hospital Full Face Mask, ...
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
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	4252	4253
Electrical /Electronic Property Problem	2625	2626
Defective Component	1871	1871
Device Alarm System	1868	1880
Device Sensing Problem	1551	1551
Incorrect, Inadequate or Imprecise Result or Readings	1454	1454
Therapeutic or Diagnostic Output Failure	1447	1459
Circuit Failure	1277	1277
Battery Problem	1273	1273
Defective Device	1149	1149
Unexpected Shutdown	1053	1053
Failure to Power Up	957	957
Degraded	868	876
Failure to Sense	847	847
Power Problem	817	829
No Display/Image	812	812
Output Problem	783	783
Gas/Air Leak	694	694
Mechanical Problem	694	694
Device Displays Incorrect Message	633	645
Defective Alarm	574	574
Display or Visual Feedback Problem	554	554
Excessive Heating	546	546
Complete Loss of Power	478	478
Failure to Run on Battery	454	454
Tidal Volume Fluctuations	400	400
Failure to Deliver	366	366
Failure to Charge	334	334
Noise, Audible	320	320
Display Difficult to Read	307	307
Break	307	307
Pressure Problem	303	303
Failure to Calibrate	294	294
Unstable	280	280
Protective Measures Problem	251	251
Failure to Shut Off	235	235
Unintended Power Up	229	229
Grounding Malfunction	207	207
Loss of Power	194	194
Self-Activation or Keying	191	191
Failure to Read Input Signal	189	189
Calibration Problem	179	179
Insufficient Flow or Under Infusion	167	167
No Flow	166	166
Infusion or Flow Problem	163	163
Computer Operating System Problem	162	162
Communication or Transmission Problem	160	160
Obstruction of Flow	159	159
Computer Software Problem	143	143
Appropriate Term/Code Not Available	140	140

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23155	23164
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	597	597
Hypoxia	116	116
Low Oxygen Saturation	113	113
Dyspnea	47	48
Death	46	46
Unspecified Respiratory Problem	21	21
Cardiac Arrest	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Respiratory Arrest	9	9
Respiratory Failure	8	8
Bradycardia	7	7
Discomfort	7	19
Injury	6	6
No Information	6	6
Increased Respiratory Rate	5	5
Cyanosis	5	5
Respiratory Distress	5	5
Respiratory Acidosis	4	4
Abnormal Blood Gases	3	3
Anxiety	3	3
Tachycardia	3	3
Respiratory Insufficiency	3	3
No Code Available	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Aspiration Pneumonitis	3	3
Pain	3	3
Fall	3	3
Pressure Sores	3	3
Bacterial Infection	3	3
Hypoventilation	3	3
Unspecified Tissue Injury	2	2
Tissue Damage	2	2
Asystole	2	2
Pneumonia	2	2
Lethargy	2	2
Cardiopulmonary Arrest	2	2
Fainting	2	2
Apnea	2	2
Pneumothorax	2	2
Vomiting	2	2
Chest Pain	2	2
Loss of consciousness	2	2
Angina	2	2
Wheezing	2	2
Pulmonary Emphysema	2	2
Ventilator Dependent	1	1