TPLC - Total Product Life Cycle

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Device	ventilator, non-continuous (respirator)
Regulation Description	Noncontinuous ventilator (IPPB).
Product Code	BZD
Regulation Number	868.5905
Device Class	2

Premarket Reviews
Manufacturer	Decision
3B MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BMC MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
DCSTAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE, LTD.
	SUBSTANTIALLY EQUIVALENT	3
FISHER AND PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GENADYNE BIOTECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS RESPIRONICS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESMED CORP
	SUBSTANTIALLY EQUIVALENT	7
RESMED PTY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
SLEEPRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOMNETICS INTERNATIONAL, INC. (DBA TRANSCEND INC)
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLELL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	265519	265660
Contamination	12795	12810
Adverse Event Without Identified Device or Use Problem	3070	3076
Corroded	2470	2470
Overheating of Device	1962	1964
Nonstandard Device	770	864
No Apparent Adverse Event	710	710
Device Emits Odor	661	676
Insufficient Information	486	487
Material Integrity Problem	412	412
Patient-Device Incompatibility	398	419
Smoking	371	374
Excessive Heating	289	289
Contamination /Decontamination Problem	275	277
Noise, Audible	273	278
Power Problem	249	249
Device Contamination with Chemical or Other Material	213	215
Electrical /Electronic Property Problem	209	209
Temperature Problem	207	207
Patient Device Interaction Problem	175	178
Fire	174	175
Failure to Power Up	170	170
Thermal Decomposition of Device	160	162
Circuit Failure	158	159
Particulates	113	124
Mechanical Problem	93	93
Unexpected Shutdown	88	90
Activation Problem	84	84
Display or Visual Feedback Problem	64	64
Break	62	67
Product Quality Problem	55	71
Sparking	54	54
Defective Device	53	58
Appropriate Term/Code Not Available	51	52
Unraveled Material	49	49
Complete Loss of Power	48	48
Pressure Problem	46	47
Decrease in Pressure	41	41
Leak/Splash	40	41
Obstruction of Flow	40	40
Environmental Particulates	39	39
Unintended Movement	39	39
Use of Device Problem	39	39
Increase in Pressure	37	37
Peeled/Delaminated	37	37
Crack	36	36
Material Disintegration	36	36
Insufficient Heating	33	33
Contamination of Device Ingredient or Reagent	32	32
Melted	31	32

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	180076	180238
Unspecified Respiratory Problem	35765	35784
Headache	27425	27467
Dizziness	20021	20030
Cancer	19542	19550
Asthma	15568	15573
Dyspnea	12868	12881
Unspecified Kidney or Urinary Problem	11360	11362
Respiratory Tract Infection	9835	9838
Sore Throat	8431	8438
Cough	8288	8316
Skin Inflammation/ Irritation	7562	7568
Inflammation	7054	7055
Nausea	6993	7004
Vomiting	5605	5609
Hypersensitivity/Allergic reaction	5099	5101
Insufficient Information	4828	4842
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4553	4563
Unspecified Heart Problem	3935	3935
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2476	2477
Dry Mouth	2045	2049
Chest Pain	1685	1691
Pneumonia	1605	1605
Heart Failure/Congestive Heart Failure	1441	1441
Pulmonary Dysfunction	1373	1373
Sleep Dysfunction	1265	1279
Epistaxis	1141	1143
Bronchitis	1124	1127
Fatigue	1111	1120
Liver Damage/Dysfunction	1064	1064
Nodule	956	958
Respiratory Failure	690	690
Dry Eye(s)	619	619
Stroke/CVA	595	595
Unspecified Eye / Vision Problem	591	592
Pain	583	590
High Blood Pressure/ Hypertension	539	539
Apnea	520	520
Breast Cancer	518	518
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	393	397
Swelling/ Edema	383	386
Choking	362	365
Myocardial Infarction	347	347
Nasal Obstruction	340	341
Wheezing	337	338
Fibrosis	332	332