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
APEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
1. K182394 WiZARD 310/320 Series CPAP Mask
2. K193206 WiZARD 510 Nasal Mask
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	5
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	2
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESMED, LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	7
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
SLEEPRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOMNETICS INTERNATIONAL, INC. (DBA TRANSCEND INC)
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYSMED (CHINA) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLELL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	265525	265666
Contamination	12801	12816
Adverse Event Without Identified Device or Use Problem	3098	3104
Corroded	2470	2470
Overheating of Device	1966	1968
Nonstandard Device	771	865
No Apparent Adverse Event	711	711
Device Emits Odor	666	682
Insufficient Information	510	511
Material Integrity Problem	412	412
Patient-Device Incompatibility	406	427
Smoking	377	380
Excessive Heating	289	289
Noise, Audible	277	282
Contamination /Decontamination Problem	275	277
Power Problem	252	252
Fire	219	220
Device Contamination with Chemical or Other Material	215	217
Electrical /Electronic Property Problem	211	211
Temperature Problem	210	215
Patient Device Interaction Problem	177	180
Failure to Power Up	172	172
Thermal Decomposition of Device	164	166
Circuit Failure	158	159
Mechanical Problem	143	143
Particulates	113	124
Unexpected Shutdown	88	90
Activation Problem	84	84
Break	80	85
Display or Visual Feedback Problem	65	65
Product Quality Problem	58	76
Disconnection	58	59
Defective Device	57	65
Pressure Problem	56	65
Sparking	54	54
Appropriate Term/Code Not Available	51	52
Obstruction of Flow	49	49
Unraveled Material	49	49
Complete Loss of Power	48	48
Decrease in Pressure	42	42
Leak/Splash	41	42
Use of Device Problem	40	40
Unintended Movement	40	40
Environmental Particulates	39	39
Detachment of Device or Device Component	39	43
Increase in Pressure	38	38
Peeled/Delaminated	37	37
Therapeutic or Diagnostic Output Failure	36	39
Material Disintegration	36	36
Crack	36	36

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	180093	180255
Unspecified Respiratory Problem	35765	35784
Headache	27426	27468
Dizziness	20022	20031
Cancer	19544	19552
Asthma	15569	15574
Dyspnea	12884	12898
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	6994	7005
Vomiting	5605	5609
Hypersensitivity/Allergic reaction	5099	5101
Insufficient Information	4831	4845
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)	2477	2478
Dry Mouth	2045	2049
Chest Pain	1686	1692
Pneumonia	1607	1607
Heart Failure/Congestive Heart Failure	1441	1441
Pulmonary Dysfunction	1373	1373
Sleep Dysfunction	1265	1279
Epistaxis	1144	1146
Bronchitis	1125	1128
Fatigue	1112	1121
Liver Damage/Dysfunction	1064	1064
Nodule	956	958
Respiratory Failure	692	692
Dry Eye(s)	619	619
Stroke/CVA	595	595
Unspecified Eye / Vision Problem	591	592
Pain	585	593
High Blood Pressure/ Hypertension	540	540
Apnea	520	520
Breast Cancer	518	518
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	394	398
Swelling/ Edema	383	386
Choking	363	366
Myocardial Infarction	347	347
Nasal Obstruction	340	341
Wheezing	337	338
Fibrosis	332	332