TPLC - Total Product Life Cycle

show TPLC since

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
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3840	3841
Electrical /Electronic Property Problem	2430	2431
Device Sensing Problem	1460	1460
Circuit Failure	1148	1148
Device Alarm System	1101	1113
Unexpected Shutdown	922	922
Failure to Sense	823	823
Degraded	794	802
Battery Problem	774	774
Power Problem	678	690
Gas/Air Leak	613	613
Mechanical Problem	586	586
Failure to Power Up	543	543
Excessive Heating	533	533
Complete Loss of Power	466	466
No Display/Image	451	451
Failure to Run on Battery	443	443
Failure to Deliver	348	348
Defective Alarm	343	343
Tidal Volume Fluctuations	334	334
Display Difficult to Read	287	287
Unstable	273	273
Display or Visual Feedback Problem	228	228
Unintended Power Up	218	218
Failure to Charge	217	217
Defective Component	210	210
Grounding Malfunction	197	197
Pressure Problem	192	192
Insufficient Flow or Under Infusion	154	154
Communication or Transmission Problem	149	149
Obstruction of Flow	148	148
Computer Software Problem	129	129
No Flow	128	128
Noise, Audible	115	115
Increase in Pressure	106	106
Infusion or Flow Problem	104	104
Insufficient Information	103	103
Failure to Shut Off	99	99
Volume Accuracy Problem	90	90
Therapeutic or Diagnostic Output Failure	84	96
Improper Flow or Infusion	80	80
No Audible Alarm	80	80
Adverse Event Without Identified Device or Use Problem	73	73
Incorrect, Inadequate or Imprecise Result or Readings	59	59
Material Integrity Problem	56	56
Failure to Calibrate	52	52
Break	50	50
Failure to Read Input Signal	49	49
Mechanical Jam	49	49
Decrease in Pressure	48	48

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21401	21410
Insufficient Information	489	489
Hypoxia	111	111
Low Oxygen Saturation	75	75
Dyspnea	43	44
Unspecified Respiratory Problem	19	19
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
Cyanosis	5	5
Increased Respiratory Rate	5	5
Death	4	4
Bradycardia	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
Anxiety	3	3
Pain	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Respiratory Acidosis	3	3
Lethargy	2	2
Loss of consciousness	2	2
Unspecified Tissue Injury	2	2
Tachycardia	2	2
Asystole	2	2
Pneumonia	2	2
Fall	2	2
Chest Pain	2	2
Angina	2	2
Apnea	2	2
Pneumothorax	2	2
Wheezing	2	2
Pulmonary Emphysema	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