TPLC - Total Product Life Cycle

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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
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	4032	4033
Defective Component	1871	1871
Electrical /Electronic Property Problem	1844	1845
Device Alarm System	1792	1804
Device Sensing Problem	1482	1482
Incorrect, Inadequate or Imprecise Result or Readings	1450	1450
Therapeutic or Diagnostic Output Failure	1447	1459
Battery Problem	1268	1268
Defective Device	1149	1149
Unexpected Shutdown	1003	1003
Failure to Power Up	935	935
Power Problem	815	827
Output Problem	782	782
No Display/Image	773	773
Failure to Sense	721	721
Gas/Air Leak	654	654
Mechanical Problem	646	646
Device Displays Incorrect Message	633	645
Defective Alarm	572	572
Circuit Failure	568	568
Display or Visual Feedback Problem	546	546
Excessive Heating	517	517
Complete Loss of Power	400	400
Failure to Run on Battery	397	397
Tidal Volume Fluctuations	352	352
Failure to Deliver	326	326
Noise, Audible	319	319
Break	307	307
Failure to Charge	301	301
Pressure Problem	300	300
Failure to Calibrate	294	294
Display Difficult to Read	279	279
Protective Measures Problem	249	249
Unstable	234	234
Failure to Shut Off	229	229
Unintended Power Up	223	223
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	161	161
Infusion or Flow Problem	158	158
Grounding Malfunction	152	152
Communication or Transmission Problem	150	150
Temperature Problem	140	140
Appropriate Term/Code Not Available	139	139
Obstruction of Flow	137	137
Computer Software Problem	132	132

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20383	20392
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	589	589
Hypoxia	112	112
Low Oxygen Saturation	104	104
Death	46	46
Dyspnea	36	37
Unspecified Respiratory Problem	19	19
Cardiac Arrest	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	9	9
Respiratory Failure	7	7
Discomfort	7	19
Bradycardia	6	6
No Information	6	6
Injury	6	6
Increased Respiratory Rate	5	5
Respiratory Distress	5	5
Respiratory Acidosis	4	4
Tachycardia	3	3
Aspiration Pneumonitis	3	3
Hypoventilation	3	3
No Code Available	3	3
Pain	3	3
Abnormal Blood Gases	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
Cyanosis	2	2
Headache	1	1
Infiltration into Tissue	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1
Cancer	1	1