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
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CRITICAL CARE AB
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN ORANGEMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inadequate User Interface	3458	3458
Electrical /Electronic Property Problem	1563	1563
Device Sensing Problem	1343	1343
Device Alarm System	1166	1166
Battery Problem	1005	1005
Unexpected Shutdown	913	913
Defective Component	817	817
Power Problem	729	729
Failure to Power Up	691	691
Gas/Air Leak	555	555
Mechanical Problem	528	528
Failure to Sense	508	508
Defective Alarm	495	495
No Display/Image	492	492
Excessive Heating	481	481
Therapeutic or Diagnostic Output Failure	439	439
Circuit Failure	394	394
Device Displays Incorrect Message	324	324
Failure to Run on Battery	308	308
Complete Loss of Power	287	287
Failure to Deliver	267	267
Tidal Volume Fluctuations	257	257
Display or Visual Feedback Problem	255	255
Defective Device	244	244
Display Difficult to Read	232	232
Failure to Charge	226	226
Noise, Audible	214	214
Pressure Problem	211	211
Unintended Power Up	194	194
Incorrect, Inadequate or Imprecise Result or Readings	167	167
Failure to Shut Off	153	153
Failure to Calibrate	151	151
Unstable	148	148
No Flow	139	139
Break	137	137
Output Problem	136	136
Insufficient Flow or Under Infusion	135	135
Failure to Read Input Signal	115	115
Obstruction of Flow	111	111
Infusion or Flow Problem	111	111
Grounding Malfunction	111	111
Increase in Pressure	109	109
Communication or Transmission Problem	103	103
Self-Activation or Keying	102	102
Insufficient Information	100	100
Volume Accuracy Problem	96	96
Computer Software Problem	91	91
Temperature Problem	88	88
Improper Flow or Infusion	85	85
Protective Measures Problem	82	82

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18234	18234
No Patient Involvement	1499	1499
No Known Impact Or Consequence To Patient	713	713
Insufficient Information	571	571
No Consequences Or Impact To Patient	390	390
Hypoxia	106	106
Low Oxygen Saturation	89	89
Death	29	29
Dyspnea	29	29
Unspecified Respiratory Problem	18	18
Cardiac Arrest	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	9	9
Discomfort	7	7
Bradycardia	6	6
Respiratory Failure	6	6
Injury	6	6
Increased Respiratory Rate	5	5
Respiratory Distress	4	4
Tachycardia	3	3
Aspiration Pneumonitis	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
Respiratory Acidosis	3	3
Tissue Damage	2	2
Asystole	2	2
Pneumonia	2	2
Fall	2	2
Cardiopulmonary Arrest	2	2
Fainting	2	2
Chest Pain	2	2
Loss of consciousness	2	2
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Pulmonary Emphysema	2	2
Apnea	2	2
Lethargy	2	2
Cyanosis	2	2
Headache	1	1
Infiltration into Tissue	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1
Therapeutic Response, Decreased	1	1
Pressure Sores	1	1
Cancer	1	1
Unspecified Vascular Problem	1	1
Low Blood Pressure/ Hypotension	1	1