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	3425	3425
Defective Component	1866	1866
Device Alarm System	1538	1538
Therapeutic or Diagnostic Output Failure	1447	1447
Incorrect, Inadequate or Imprecise Result or Readings	1441	1441
Device Sensing Problem	1275	1275
Battery Problem	1261	1261
Defective Device	1148	1148
Failure to Power Up	851	851
Power Problem	785	785
Output Problem	774	774
Unexpected Shutdown	767	767
No Display/Image	642	642
Device Displays Incorrect Message	633	633
Electrical /Electronic Property Problem	569	569
Defective Alarm	548	548
Display or Visual Feedback Problem	528	528
Gas/Air Leak	525	525
Mechanical Problem	445	445
Excessive Heating	440	440
Failure to Sense	334	334
Noise, Audible	319	319
Break	307	307
Failure to Calibrate	293	293
Pressure Problem	289	289
Protective Measures Problem	242	242
Tidal Volume Fluctuations	234	234
Failure to Run on Battery	228	228
Failure to Charge	223	223
Failure to Deliver	217	217
Failure to Shut Off	211	211
Display Difficult to Read	200	200
Loss of Power	194	194
Self-Activation or Keying	191	191
Failure to Read Input Signal	189	189
Complete Loss of Power	187	187
Unintended Power Up	183	183
Calibration Problem	179	179
Circuit Failure	174	174
Computer Operating System Problem	162	162
No Flow	161	161
Infusion or Flow Problem	151	151
Appropriate Term/Code Not Available	139	139
Temperature Problem	139	139
Insufficient Flow or Under Infusion	133	133
Poor Quality Image	116	116
Improper Flow or Infusion	114	114
Increase in Pressure	111	111
Volume Accuracy Problem	109	109
Insufficient Information	104	104

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15069	15069
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	563	563
Hypoxia	103	103
Low Oxygen Saturation	88	88
Death	46	46
Dyspnea	28	28
Unspecified Respiratory Problem	16	16
Cardiac Arrest	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Respiratory Arrest	8	8
Respiratory Failure	7	7
No Information	6	6
Bradycardia	6	6
Injury	6	6
Respiratory Distress	5	5
Discomfort	5	5
Increased Respiratory Rate	4	4
No Code Available	3	3
Aspiration Pneumonitis	3	3
Tachycardia	3	3
Respiratory Insufficiency	3	3
Bacterial Infection	3	3
Respiratory Acidosis	3	3
Pain	3	3
Fall	3	3
Pressure Sores	3	3
Tissue Damage	2	2
Pneumonia	2	2
Asystole	2	2
Cardiopulmonary Arrest	2	2
Cyanosis	2	2
Lethargy	2	2
Chest Pain	2	2
Fainting	2	2
Loss of consciousness	2	2
Apnea	2	2
Pulmonary Emphysema	2	2
Hypoventilation	2	2
Distress	1	1
Convulsion/Seizure	1	1
Cardiovascular Insufficiency	1	1
Bruise/Contusion	1	1
Therapeutic Response, Decreased	1	1
Infiltration into Tissue	1	1
Ventilator Dependent	1	1
Cancer	1	1
Unspecified Vascular Problem	1	1