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
1. K191624 F&P Nivairo RT047 Vented Hospital Full Face Mask, ...
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	4007	4008
Defective Component	1870	1870
Electrical /Electronic Property Problem	1816	1816
Device Alarm System	1778	1790
Device Sensing Problem	1470	1470
Incorrect, Inadequate or Imprecise Result or Readings	1448	1448
Therapeutic or Diagnostic Output Failure	1447	1459
Battery Problem	1266	1266
Defective Device	1149	1149
Unexpected Shutdown	995	995
Failure to Power Up	930	930
Power Problem	813	825
Output Problem	782	782
No Display/Image	764	764
Failure to Sense	699	699
Gas/Air Leak	646	646
Device Displays Incorrect Message	633	645
Mechanical Problem	633	633
Defective Alarm	572	572
Circuit Failure	549	549
Display or Visual Feedback Problem	545	545
Excessive Heating	511	511
Failure to Run on Battery	389	389
Complete Loss of Power	385	385
Tidal Volume Fluctuations	341	341
Failure to Deliver	320	320
Noise, Audible	319	319
Break	307	307
Pressure Problem	299	299
Failure to Charge	297	297
Failure to Calibrate	294	294
Display Difficult to Read	278	278
Protective Measures Problem	246	246
Unstable	232	232
Failure to Shut Off	228	228
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
Infusion or Flow Problem	158	158
Insufficient Flow or Under Infusion	156	156
Grounding Malfunction	149	149
Communication or Transmission Problem	147	147
Temperature Problem	140	140
Appropriate Term/Code Not Available	139	139
Obstruction of Flow	134	134
Computer Software Problem	129	129

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	20143	20144
No Patient Involvement	7672	7672
No Known Impact Or Consequence To Patient	3030	3030
No Consequences Or Impact To Patient	1226	1226
Insufficient Information	579	579
Hypoxia	110	110
Low Oxygen Saturation	99	99
Death	46	46
Dyspnea	33	33
Unspecified Respiratory Problem	19	19
Cardiac Arrest	10	10
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
Aspiration/Inhalation	2	2
Wheezing	2	2
Apnea	2	2
Lethargy	2	2
Cyanosis	2	2
Headache	1	1
Infiltration into Tissue	1	1
Cancer	1	1
Cardiovascular Insufficiency	1	1