TPLC - Total Product Life Cycle

show TPLC since

Device	ventilator, continuous, non-life-supporting
Product Code	MNS
Regulation Number	868.5895
Device Class	2

Premarket Reviews
Manufacturer	Decision
BMC MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS RESPIRONICS, INC
	SUBSTANTIALLY EQUIVALENT	1
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	3
RESMED LTD.
	SUBSTANTIALLY EQUIVALENT	10
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
	SUBSTANTIALLY EQUIVALENT	2
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	5
SMD MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
SMD MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	1
SUNRISE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	4482	4482
Corroded	233	233
Adverse Event Without Identified Device or Use Problem	79	79
Contamination	77	77
Device Displays Incorrect Message	65	65
Nonstandard Device	46	46
Battery Problem	42	42
Device Alarm System	40	40
Electrical /Electronic Property Problem	40	40
Failure to Power Up	38	38
Unexpected Shutdown	36	36
Power Problem	28	28
Output Problem	26	26
Pressure Problem	26	26
Insufficient Information	24	24
Patient-Device Incompatibility	21	21
Therapeutic or Diagnostic Output Failure	20	20
Circuit Failure	19	19
Increase in Pressure	19	19
Protective Measures Problem	17	17
Defective Component	15	15
Device Emits Odor	14	14
Device Operates Differently Than Expected	14	14
Noise, Audible	13	13
Loss of Power	13	13
No Audible Alarm	13	13
Defective Device	12	12
Failure to Charge	12	12
Mechanical Problem	11	11
Material Integrity Problem	11	11
Failure to Calibrate	10	10
Display or Visual Feedback Problem	10	10
Self-Activation or Keying	10	10
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Decrease in Pressure	9	9
Overheating of Device	9	9
Break	9	9
Defective Alarm	7	7
No Flow	7	7
No Display/Image	7	7
Crack	6	6
Fire	6	6
Computer Operating System Problem	5	5
Component Missing	5	5
Device Inoperable	5	5
Temperature Problem	5	5
Smoking	4	4
Communication or Transmission Problem	4	4
Calibration Problem	4	4
Thermal Decomposition of Device	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2875	2875
Dyspnea	567	567
Unspecified Respiratory Problem	566	566
Headache	533	533
Dizziness	312	312
Cancer	299	299
Cough	245	245
Sore Throat	232	232
Respiratory Tract Infection	207	207
No Patient Involvement	198	198
Asthma	176	176
Unspecified Kidney or Urinary Problem	151	151
Nausea	116	116
Skin Inflammation/ Irritation	106	106
No Known Impact Or Consequence To Patient	105	105
Unspecified Heart Problem	104	104
Inflammation	100	100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	86	86
Insufficient Information	85	85
Vomiting	80	80
Hypersensitivity/Allergic reaction	78	78
No Consequences Or Impact To Patient	70	70
Dry Mouth	67	67
Chest Pain	49	49
Unspecified Hepatic or Biliary Problem	44	44
Sleep Dysfunction	43	43
Chronic Obstructive Pulmonary Disease (COPD)	36	36
Epistaxis	36	36
Heart Failure/Congestive Heart Failure	34	34
Liver Damage/Dysfunction	31	31
Stroke/CVA	31	31
Pneumonia	28	28
Fatigue	28	28
No Information	22	22
Apnea	22	22
Nodule	21	21
Respiratory Failure	19	19
Pharyngitis	17	17
Death	17	17
Cardiac Arrest	16	16
Low Oxygen Saturation	16	16
Pain	16	16
Unspecified Eye / Vision Problem	15	15
Dry Eye(s)	14	14
Atrial Fibrillation	14	14
Pulmonary Dysfunction	14	14
Renal Failure	14	14
Bronchitis	13	13
Sneezing	13	13
Unspecified Infection	12	12