TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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	3571	3571
Defective Component	1866	1866
Device Alarm System	1599	1599
Therapeutic or Diagnostic Output Failure	1447	1447
Electrical /Electronic Property Problem	1445	1445
Incorrect, Inadequate or Imprecise Result or Readings	1443	1443
Device Sensing Problem	1315	1315
Battery Problem	1264	1264
Defective Device	1148	1148
Unexpected Shutdown	879	879
Failure to Power Up	878	878
Power Problem	794	794
Output Problem	779	779
No Display/Image	675	675
Device Displays Incorrect Message	633	633
Defective Alarm	558	558
Gas/Air Leak	551	551
Display or Visual Feedback Problem	530	530
Mechanical Problem	496	496
Excessive Heating	458	458
Failure to Sense	398	398
Noise, Audible	319	319
Break	307	307
Failure to Calibrate	293	293
Pressure Problem	290	290
Circuit Failure	268	268
Tidal Volume Fluctuations	265	265
Failure to Run on Battery	263	263
Complete Loss of Power	249	249
Protective Measures Problem	243	243
Failure to Deliver	242	242
Failure to Charge	237	237
Failure to Shut Off	216	216
Display Difficult to Read	213	213
Loss of Power	194	194
Self-Activation or Keying	191	191
Unintended Power Up	189	189
Failure to Read Input Signal	189	189
Calibration Problem	179	179
No Flow	163	163
Computer Operating System Problem	162	162
Infusion or Flow Problem	151	151
Appropriate Term/Code Not Available	139	139
Temperature Problem	139	139
Insufficient Flow or Under Infusion	139	139
Poor Quality Image	116	116
Improper Flow or Infusion	115	115
Increase in Pressure	111	111
Insufficient Information	109	109
Volume Accuracy Problem	109	109

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16931	16931
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	567	567
Hypoxia	105	105
Low Oxygen Saturation	92	92
Death	46	46
Dyspnea	28	28
Unspecified Respiratory Problem	17	17
Cardiac Arrest	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	8	8
Respiratory Failure	7	7
Bradycardia	6	6
No Information	6	6
Injury	6	6
Respiratory Distress	5	5
Discomfort	5	5
Increased Respiratory Rate	4	4
Tachycardia	3	3
Pain	3	3
Fall	3	3
Bacterial Infection	3	3
Pressure Sores	3	3
Respiratory Acidosis	3	3
Respiratory Insufficiency	3	3
No Code Available	3	3
Aspiration Pneumonitis	3	3
Chronic Obstructive Pulmonary Disease (COPD)	2	2
Loss of consciousness	2	2
Chest Pain	2	2
Pulmonary Emphysema	2	2
Fainting	2	2
Cardiopulmonary Arrest	2	2
Hypoventilation	2	2
Apnea	2	2
Lethargy	2	2
Pneumonia	2	2
Asystole	2	2
Tissue Damage	2	2
Cyanosis	2	2
Infiltration into Tissue	1	1
Cancer	1	1
Unspecified Vascular Problem	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoxia in Utero	1	1
Cardiovascular Insufficiency	1	1
Ventilator Dependent	1	1
Convulsion/Seizure	1	1