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
BREAS MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
FISHER AND PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CRITICAL CARE AB
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN ORANGEMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESMED GERMANY INC.
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS CALIFORNIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS INC.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Displays Incorrect Message	4199	4199
Inadequate User Interface	3432	3432
Defective Component	1979	1979
Device Alarm System	1844	1844
Device Operates Differently Than Expected	1816	1816
Battery Problem	1751	1751
Failure to Power Up	1516	1516
Therapeutic or Diagnostic Output Failure	1451	1451
Incorrect, Inadequate or Imprecise Result or Readings	1450	1450
Device Sensing Problem	1331	1331
Defective Device	1282	1282
Device Inoperable	1242	1242
No Display/Image	1084	1084
Power Problem	974	974
Output Problem	802	802
Unexpected Shutdown	774	774
Electrical /Electronic Property Problem	605	605
Display or Visual Feedback Problem	594	594
Loss of Power	589	589
Defective Alarm	585	585
Gas/Air Leak	553	553
Mechanical Problem	494	494
Break	466	466
Failure to Charge	447	447
Excessive Heating	440	440
Failure to Sense	417	417
Pressure Problem	399	399
Temperature Problem	393	393
Failure to Calibrate	370	370
Noise, Audible	355	355
Tidal Volume Fluctuations	317	317
Failure to Read Input Signal	292	292
Calibration Problem	259	259
Protective Measures Problem	253	253
Failure to Shut Off	250	250
Failure to Run on Battery	239	239
Nonstandard Device	238	238
Failure to Deliver	231	231
Self-Activation or Keying	229	229
No Flow	225	225
Appropriate Term/Code Not Available	204	204
Display Difficult to Read	204	204
Leak/Splash	198	198
Computer Operating System Problem	196	196
Complete Loss of Power	187	187
Failure of Device to Self-Test	186	186
Circuit Failure	184	184
Unintended Power Up	183	183
Infusion or Flow Problem	161	161
Communication or Transmission Problem	151	151

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15074	15074
No Patient Involvement	12431	12431
No Known Impact Or Consequence To Patient	6640	6640
No Consequences Or Impact To Patient	2695	2695
Insufficient Information	565	565
Low Oxygen Saturation	142	142
Death	122	122
Hypoxia	107	107
No Information	105	105
Dyspnea	30	30
Respiratory Distress	22	22
Unspecified Respiratory Problem	16	16
No Code Available	16	16
Cardiac Arrest	13	13
Injury	12	12
Bradycardia	11	11
Cardiopulmonary Arrest	10	10
Respiratory Failure	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Pressure Sores	9	9
Respiratory Arrest	8	8
Patient Problem/Medical Problem	6	6
Cyanosis	5	5
Increased Respiratory Rate	5	5
Discomfort	5	5
Tachycardia	4	4
Pain	4	4
Bacterial Infection	4	4
Loss of consciousness	4	4
Hypoventilation	4	4
Respiratory Insufficiency	3	3
Pulmonary Emphysema	3	3
Respiratory Acidosis	3	3
Chest Pain	3	3
Complaint, Ill-Defined	3	3
Fall	3	3
Aspiration Pneumonitis	3	3
Pneumonia	3	3
Cognitive Changes	2	2
Abdominal Distention	2	2
Ventilator Dependent	2	2
Abnormal Blood Gases	2	2
Fainting	2	2
Brain Injury	2	2
Bruise/Contusion	2	2
Tissue Damage	2	2
Pneumothorax	2	2
Apnea	2	2
Lethargy	2	2
Anxiety	2	2