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	1
BMC MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	3
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	3
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS INC.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYSMED (CHINA) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	223391	223392
Contamination	4601	4601
Corroded	2463	2463
Adverse Event Without Identified Device or Use Problem	2448	2448
Nonstandard Device	758	758
Insufficient Information	427	427
Device Emits Odor	411	411
Patient-Device Incompatibility	399	399
No Apparent Adverse Event	380	380
Material Integrity Problem	370	370
Overheating of Device	353	353
Smoking	308	308
Excessive Heating	187	187
Power Problem	182	182
Noise, Audible	180	180
Patient Device Interaction Problem	161	161
Fire	161	161
Electrical /Electronic Property Problem	160	160
Temperature Problem	150	150
Contamination /Decontamination Problem	145	145
Failure to Power Up	141	141
Device Contamination with Chemical or Other Material	125	125
Particulates	110	110
Circuit Failure	106	106
Mechanical Problem	100	100
Thermal Decomposition of Device	88	88
Unexpected Shutdown	61	61
Break	59	59
Display or Visual Feedback Problem	55	55
Product Quality Problem	51	51
Activation Problem	51	51
Defective Device	46	46
Pressure Problem	45	45
Complete Loss of Power	45	45
Unraveled Material	42	42
Sparking	41	41
Appropriate Term/Code Not Available	41	41
Obstruction of Flow	37	37
Peeled/Delaminated	37	37
Decrease in Pressure	36	36
Leak/Splash	34	34
Disconnection	33	33
Material Disintegration	33	33
Use of Device Problem	32	32
Increase in Pressure	31	31
Crack	31	31
Insufficient Heating	28	28
Melted	27	27
Environmental Particulates	27	27
Therapeutic or Diagnostic Output Failure	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138582	138582
Unspecified Respiratory Problem	34757	34758
Headache	26794	26794
Dizziness	19601	19601
Cancer	18985	18985
Asthma	15228	15229
Dyspnea	12535	12535
Unspecified Kidney or Urinary Problem	11115	11115
Respiratory Tract Infection	9809	9809
Sore Throat	8279	8279
Cough	8032	8032
Skin Inflammation/ Irritation	7401	7401
Inflammation	6853	6854
Nausea	6830	6830
Vomiting	5456	5456
Hypersensitivity/Allergic reaction	4987	4987
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4352	4352
Insufficient Information	4127	4127
Unspecified Heart Problem	3857	3857
Unspecified Hepatic or Biliary Problem	3258	3258
Chronic Obstructive Pulmonary Disease (COPD)	2352	2352
Dry Mouth	1986	1986
Chest Pain	1640	1640
Pneumonia	1543	1543
Heart Failure/Congestive Heart Failure	1388	1388
Pulmonary Dysfunction	1238	1238
Sleep Dysfunction	1219	1219
Epistaxis	1111	1111
Fatigue	1060	1060
Liver Damage/Dysfunction	1057	1057
Bronchitis	1056	1056
Nodule	910	910
Respiratory Failure	655	655
Dry Eye(s)	608	608
Unspecified Eye / Vision Problem	568	568
Stroke/CVA	567	567
Pain	559	559
High Blood Pressure/ Hypertension	517	517
Breast Cancer	489	489
Apnea	482	482
Lymphoma	454	454
Sneezing	453	453
Cardiovascular Insufficiency	427	427
Burning Sensation	381	381
Swelling/ Edema	371	371
Choking	344	344
Nasal Obstruction	339	339
Wheezing	320	320
Myocardial Infarction	319	319
Rash	318	318