TPLC - Total Product Life Cycle

show TPLC since

Device	ventilator, continuous, minimal ventilatory support, facility use
Regulation Description	Continuous ventilator.
Product Code	MNT
Regulation Number	868.5895
Device Class	2

Premarket Reviews
Manufacturer	Decision
BREAS MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1
1. K240779 Vivo 3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	4075	4076
Electrical /Electronic Property Problem	1976	1977
Defective Component	1871	1871
Device Alarm System	1804	1816
Device Sensing Problem	1501	1501
Incorrect, Inadequate or Imprecise Result or Readings	1451	1451
Therapeutic or Diagnostic Output Failure	1447	1459
Battery Problem	1268	1268
Defective Device	1149	1149
Unexpected Shutdown	1017	1017
Failure to Power Up	946	946
Power Problem	815	827
No Display/Image	785	785
Output Problem	782	782
Failure to Sense	753	753
Circuit Failure	694	694
Gas/Air Leak	663	663
Mechanical Problem	655	655
Device Displays Incorrect Message	633	645
Defective Alarm	572	572
Display or Visual Feedback Problem	550	550
Excessive Heating	526	526
Complete Loss of Power	421	421
Failure to Run on Battery	405	405
Tidal Volume Fluctuations	364	364
Failure to Deliver	332	332
Noise, Audible	319	319
Break	307	307
Failure to Charge	305	305
Pressure Problem	301	301
Failure to Calibrate	294	294
Display Difficult to Read	287	287
Protective Measures Problem	251	251
Unstable	240	240
Failure to Shut Off	231	231
Unintended Power Up	224	224
Loss of Power	194	194
Self-Activation or Keying	191	191
Failure to Read Input Signal	189	189
Calibration Problem	179	179
No Flow	166	166
Computer Operating System Problem	162	162
Insufficient Flow or Under Infusion	162	162
Infusion or Flow Problem	159	159
Grounding Malfunction	157	157
Communication or Transmission Problem	152	152
Obstruction of Flow	145	145
Appropriate Term/Code Not Available	140	140
Temperature Problem	140	140
Computer Software Problem	133	133

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20802	20811
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	593	593
Hypoxia	112	112
Low Oxygen Saturation	110	110
Death	46	46
Dyspnea	42	43
Unspecified Respiratory Problem	19	19
Cardiac Arrest	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Respiratory Arrest	9	9
Respiratory Failure	8	8
Discomfort	7	19
Bradycardia	6	6
No Information	6	6
Injury	6	6
Increased Respiratory Rate	5	5
Respiratory Distress	5	5
Cyanosis	4	4
Respiratory Acidosis	4	4
Tachycardia	3	3
Aspiration Pneumonitis	3	3
Hypoventilation	3	3
No Code Available	3	3
Abnormal Blood Gases	3	3
Pain	3	3
Fall	3	3
Bacterial Infection	3	3
Respiratory Insufficiency	3	3
Pressure Sores	3	3
Tissue Damage	2	2
Asystole	2	2
Pneumonia	2	2
Cardiopulmonary Arrest	2	2
Fainting	2	2
Vomiting	2	2
Chest Pain	2	2
Loss of consciousness	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Pulmonary Emphysema	2	2
Wheezing	2	2
Apnea	2	2
Lethargy	2	2
Headache	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1
Infiltration into Tissue	1	1
Cancer	1	1