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	2
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	5
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
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	252004	252145
Contamination	11342	11357
Adverse Event Without Identified Device or Use Problem	2998	3004
Corroded	2467	2467
Overheating of Device	1867	1869
Nonstandard Device	768	862
No Apparent Adverse Event	685	685
Device Emits Odor	651	666
Insufficient Information	464	465
Material Integrity Problem	401	401
Patient-Device Incompatibility	396	417
Smoking	359	362
Excessive Heating	275	275
Contamination /Decontamination Problem	272	274
Noise, Audible	272	277
Power Problem	249	249
Device Contamination with Chemical or Other Material	209	211
Electrical /Electronic Property Problem	208	208
Temperature Problem	201	201
Patient Device Interaction Problem	173	176
Failure to Power Up	170	170
Fire	170	171
Circuit Failure	157	158
Thermal Decomposition of Device	148	150
Particulates	112	123
Mechanical Problem	93	93
Unexpected Shutdown	84	86
Activation Problem	84	84
Display or Visual Feedback Problem	63	63
Break	60	65
Product Quality Problem	53	69
Sparking	52	52
Unraveled Material	49	49
Defective Device	49	54
Appropriate Term/Code Not Available	48	49
Complete Loss of Power	47	47
Pressure Problem	46	47
Decrease in Pressure	41	41
Obstruction of Flow	40	40
Leak/Splash	40	41
Environmental Particulates	39	39
Use of Device Problem	37	37
Peeled/Delaminated	37	37
Increase in Pressure	36	36
Crack	36	36
Material Disintegration	36	36
Unintended Movement	35	35
Insufficient Heating	33	33
Contamination of Device Ingredient or Reagent	32	32
Melted	30	31

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	166436	166598
Unspecified Respiratory Problem	35754	35773
Headache	27415	27457
Dizziness	20015	20024
Cancer	19538	19546
Asthma	15564	15569
Dyspnea	12847	12860
Unspecified Kidney or Urinary Problem	11357	11359
Respiratory Tract Infection	9834	9837
Sore Throat	8426	8433
Cough	8275	8303
Skin Inflammation/ Irritation	7561	7567
Inflammation	7052	7053
Nausea	6992	7003
Vomiting	5605	5609
Hypersensitivity/Allergic reaction	5097	5099
Insufficient Information	4793	4807
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4550	4560
Unspecified Heart Problem	3934	3934
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2475	2476
Dry Mouth	2041	2045
Chest Pain	1685	1691
Pneumonia	1604	1604
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1371	1371
Sleep Dysfunction	1263	1277
Epistaxis	1139	1141
Bronchitis	1124	1127
Fatigue	1108	1117
Liver Damage/Dysfunction	1065	1065
Nodule	955	957
Respiratory Failure	689	689
Dry Eye(s)	619	619
Stroke/CVA	594	594
Unspecified Eye / Vision Problem	590	591
Pain	578	585
High Blood Pressure/ Hypertension	538	538
Breast Cancer	518	518
Apnea	515	515
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	392	396
Swelling/ Edema	381	384
Choking	360	363
Myocardial Infarction	345	345
Nasal Obstruction	340	341
Wheezing	335	336
Fibrosis	332	332