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
BMC MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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	5
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
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4. K241469 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mas ...
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6. K241830 Mojo Full Face Vented Mask; Veraseal 2 Full Face V ...
7. K251847 Sleepnet Arie Full Face Vented Mask; Sleepnet Arie ...
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	260007	260148
Contamination	12745	12760
Adverse Event Without Identified Device or Use Problem	3058	3064
Corroded	2467	2467
Overheating of Device	1947	1949
Nonstandard Device	770	864
No Apparent Adverse Event	706	706
Device Emits Odor	665	681
Insufficient Information	504	505
Patient-Device Incompatibility	405	426
Material Integrity Problem	404	404
Smoking	372	375
Excessive Heating	287	287
Noise, Audible	277	282
Contamination /Decontamination Problem	275	277
Power Problem	252	252
Fire	218	219
Device Contamination with Chemical or Other Material	215	217
Electrical /Electronic Property Problem	211	211
Temperature Problem	209	214
Patient Device Interaction Problem	176	179
Failure to Power Up	172	172
Thermal Decomposition of Device	163	165
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
Unraveled Material	49	49
Appropriate Term/Code Not Available	49	50
Obstruction of Flow	49	49
Complete Loss of Power	48	48
Decrease in Pressure	42	42
Leak/Splash	41	42
Unintended Movement	40	40
Use of Device Problem	39	39
Environmental Particulates	39	39
Increase in Pressure	38	38
Detachment of Device or Device Component	37	41
Peeled/Delaminated	37	37
Material Disintegration	36	36
Crack	36	36
Therapeutic or Diagnostic Output Failure	36	39

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	174547	174709
Unspecified Respiratory Problem	35764	35783
Headache	27425	27467
Dizziness	20021	20030
Cancer	19544	19552
Asthma	15569	15574
Dyspnea	12878	12892
Unspecified Kidney or Urinary Problem	11358	11360
Respiratory Tract Infection	9835	9838
Sore Throat	8431	8438
Cough	8286	8314
Skin Inflammation/ Irritation	7562	7568
Inflammation	7053	7054
Nausea	6995	7006
Vomiting	5606	5610
Hypersensitivity/Allergic reaction	5098	5100
Insufficient Information	4829	4843
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4552	4562
Unspecified Heart Problem	3935	3935
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2477	2478
Dry Mouth	2044	2048
Chest Pain	1686	1692
Pneumonia	1607	1607
Heart Failure/Congestive Heart Failure	1441	1441
Pulmonary Dysfunction	1373	1373
Sleep Dysfunction	1265	1279
Epistaxis	1143	1145
Bronchitis	1125	1128
Fatigue	1112	1121
Liver Damage/Dysfunction	1065	1065
Nodule	955	957
Respiratory Failure	691	691
Dry Eye(s)	619	619
Stroke/CVA	595	595
Unspecified Eye / Vision Problem	591	592
Pain	583	591
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	382	385
Choking	362	365
Myocardial Infarction	346	346
Nasal Obstruction	340	341
Wheezing	337	338
Fibrosis	332	332