TPLC - Total Product Life Cycle

show TPLC since

Device	ventilator, continuous, minimal ventilatory support, facility use
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
1. K233643 F&P Airvo 3 NIV (PT311US)
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	3624	3624
Defective Component	1867	1867
Device Alarm System	1614	1614
Electrical /Electronic Property Problem	1490	1490
Therapeutic or Diagnostic Output Failure	1447	1447
Incorrect, Inadequate or Imprecise Result or Readings	1443	1443
Device Sensing Problem	1332	1332
Battery Problem	1264	1264
Defective Device	1148	1148
Unexpected Shutdown	913	913
Failure to Power Up	883	883
Power Problem	797	797
Output Problem	779	779
No Display/Image	681	681
Device Displays Incorrect Message	633	633
Defective Alarm	561	561
Gas/Air Leak	560	560
Display or Visual Feedback Problem	532	532
Mechanical Problem	508	508
Excessive Heating	468	468
Failure to Sense	432	432
Noise, Audible	319	319
Break	307	307
Failure to Calibrate	293	293
Circuit Failure	292	292
Pressure Problem	290	290
Failure to Run on Battery	274	274
Tidal Volume Fluctuations	271	271
Complete Loss of Power	259	259
Failure to Deliver	248	248
Protective Measures Problem	243	243
Failure to Charge	240	240
Display Difficult to Read	219	219
Failure to Shut Off	219	219
Loss of Power	194	194
Self-Activation or Keying	191	191
Unintended Power Up	191	191
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	152	152
Insufficient Flow or Under Infusion	140	140
Appropriate Term/Code Not Available	139	139
Temperature Problem	139	139
Poor Quality Image	116	116
Improper Flow or Infusion	115	115
Increase in Pressure	112	112
Insufficient Information	110	110
Volume Accuracy Problem	109	109

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	17277	17277
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	568	568
Hypoxia	105	105
Low Oxygen Saturation	92	92
Death	46	46
Dyspnea	29	29
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
Increased Respiratory Rate	5	5
Respiratory Distress	5	5
Discomfort	5	5
Aspiration Pneumonitis	3	3
Tachycardia	3	3
No Code Available	3	3
Pain	3	3
Abnormal Blood Gases	3	3
Fall	3	3
Respiratory Insufficiency	3	3
Respiratory Acidosis	3	3
Bacterial Infection	3	3
Pressure Sores	3	3
Tissue Damage	2	2
Pneumonia	2	2
Asystole	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
Hypoventilation	2	2
Apnea	2	2
Lethargy	2	2
Cyanosis	2	2
Infiltration into Tissue	1	1
Cancer	1	1
Unspecified Vascular Problem	1	1
Convulsion/Seizure	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoxia in Utero	1	1
Cardiovascular Insufficiency	1	1