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	2
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
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5. K210386 Magneto Nasal Mask
6. K210844 DreamWear Silicone Pillows Mask
7. K231313 Therapy Mask 3100 NC/SP
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
SLEEPRES, 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	252010	252151
Contamination	11348	11363
Adverse Event Without Identified Device or Use Problem	3026	3032
Corroded	2467	2467
Overheating of Device	1871	1873
Nonstandard Device	769	863
No Apparent Adverse Event	686	686
Device Emits Odor	656	672
Insufficient Information	488	489
Patient-Device Incompatibility	404	425
Material Integrity Problem	401	401
Smoking	365	368
Noise, Audible	276	281
Excessive Heating	275	275
Contamination /Decontamination Problem	272	274
Power Problem	252	252
Fire	215	216
Device Contamination with Chemical or Other Material	211	213
Electrical /Electronic Property Problem	210	210
Temperature Problem	204	209
Patient Device Interaction Problem	175	178
Failure to Power Up	172	172
Circuit Failure	157	158
Thermal Decomposition of Device	152	154
Mechanical Problem	143	143
Particulates	112	123
Unexpected Shutdown	84	86
Activation Problem	84	84
Break	78	83
Display or Visual Feedback Problem	64	64
Disconnection	58	59
Product Quality Problem	56	74
Pressure Problem	56	65
Defective Device	53	61
Sparking	52	52
Obstruction of Flow	49	49
Unraveled Material	49	49
Appropriate Term/Code Not Available	48	49
Complete Loss of Power	47	47
Decrease in Pressure	42	42
Leak/Splash	41	42
Environmental Particulates	39	39
Use of Device Problem	38	38
Peeled/Delaminated	37	37
Increase in Pressure	37	37
Crack	36	36
Material Disintegration	36	36
Unintended Movement	36	36
Detachment of Device or Device Component	36	40
Therapeutic or Diagnostic Output Failure	35	38

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	166453	166615
Unspecified Respiratory Problem	35754	35773
Headache	27416	27458
Dizziness	20016	20025
Cancer	19540	19548
Asthma	15565	15570
Dyspnea	12863	12877
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	6993	7004
Vomiting	5605	5609
Hypersensitivity/Allergic reaction	5097	5099
Insufficient Information	4796	4810
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)	2476	2477
Dry Mouth	2041	2045
Chest Pain	1686	1692
Pneumonia	1606	1606
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1371	1371
Sleep Dysfunction	1263	1277
Epistaxis	1142	1144
Bronchitis	1125	1128
Fatigue	1109	1118
Liver Damage/Dysfunction	1065	1065
Nodule	955	957
Respiratory Failure	691	691
Dry Eye(s)	619	619
Stroke/CVA	594	594
Unspecified Eye / Vision Problem	590	591
Pain	580	588
High Blood Pressure/ Hypertension	539	539
Breast Cancer	518	518
Apnea	515	515
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	393	397
Swelling/ Edema	381	384
Choking	361	364
Myocardial Infarction	345	345
Nasal Obstruction	340	341
Wheezing	335	336
Fibrosis	332	332