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
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	6
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	242288	242401
Contamination	11147	11153
Adverse Event Without Identified Device or Use Problem	2952	2958
Corroded	2467	2467
Overheating of Device	1834	1836
Nonstandard Device	765	859
No Apparent Adverse Event	661	661
Device Emits Odor	635	651
Insufficient Information	483	484
Patient-Device Incompatibility	404	425
Material Integrity Problem	396	396
Smoking	358	361
Noise, Audible	274	279
Contamination /Decontamination Problem	272	274
Excessive Heating	268	268
Power Problem	250	250
Device Contamination with Chemical or Other Material	209	211
Fire	209	210
Electrical /Electronic Property Problem	208	208
Temperature Problem	202	207
Patient Device Interaction Problem	172	175
Failure to Power Up	171	171
Circuit Failure	155	156
Mechanical Problem	143	143
Thermal Decomposition of Device	139	141
Particulates	113	124
Activation Problem	84	84
Unexpected Shutdown	81	83
Break	74	79
Display or Visual Feedback Problem	64	64
Disconnection	58	59
Pressure Problem	55	64
Product Quality Problem	54	72
Defective Device	53	61
Sparking	52	52
Appropriate Term/Code Not Available	48	49
Obstruction of Flow	47	47
Complete Loss of Power	47	47
Unraveled Material	45	45
Leak/Splash	41	42
Decrease in Pressure	39	39
Environmental Particulates	39	39
Peeled/Delaminated	37	37
Use of Device Problem	37	37
Increase in Pressure	36	36
Crack	35	35
Therapeutic or Diagnostic Output Failure	35	38
Unintended Movement	35	35
Material Disintegration	34	34
Detachment of Device or Device Component	33	37

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	156688	156822
Unspecified Respiratory Problem	35701	35720
Headache	27389	27431
Dizziness	19999	20008
Cancer	19506	19514
Asthma	15543	15548
Dyspnea	12844	12858
Unspecified Kidney or Urinary Problem	11343	11345
Respiratory Tract Infection	9834	9837
Sore Throat	8421	8428
Cough	8261	8289
Skin Inflammation/ Irritation	7551	7557
Inflammation	7044	7045
Nausea	6990	7001
Vomiting	5601	5605
Hypersensitivity/Allergic reaction	5089	5091
Insufficient Information	4730	4744
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4541	4551
Unspecified Heart Problem	3926	3926
Unspecified Hepatic or Biliary Problem	3369	3369
Chronic Obstructive Pulmonary Disease (COPD)	2474	2475
Dry Mouth	2038	2042
Chest Pain	1683	1689
Pneumonia	1601	1601
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1365	1365
Sleep Dysfunction	1258	1272
Epistaxis	1142	1144
Bronchitis	1123	1126
Fatigue	1106	1115
Liver Damage/Dysfunction	1065	1065
Nodule	952	954
Respiratory Failure	688	688
Dry Eye(s)	618	618
Stroke/CVA	593	593
Unspecified Eye / Vision Problem	590	591
Pain	577	585
High Blood Pressure/ Hypertension	539	539
Breast Cancer	518	518
Apnea	514	514
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	391	395
Swelling/ Edema	376	379
Choking	359	362
Myocardial Infarction	341	341
Nasal Obstruction	340	341
Wheezing	335	336
Fibrosis	331	331