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 LTD
	SUBSTANTIALLY EQUIVALENT	3
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
1. K200565 Galapogos
2. K241216 myAir
3. K241939 EasyCare Tx 2
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS INC.
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
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	223394	223395
Contamination	4604	4604
Corroded	2463	2463
Adverse Event Without Identified Device or Use Problem	2463	2463
Nonstandard Device	759	759
Insufficient Information	443	443
Device Emits Odor	413	413
Patient-Device Incompatibility	400	400
No Apparent Adverse Event	380	380
Material Integrity Problem	370	370
Overheating of Device	354	354
Smoking	309	309
Excessive Heating	187	187
Fire	184	184
Power Problem	183	183
Noise, Audible	183	183
Patient Device Interaction Problem	163	163
Electrical /Electronic Property Problem	161	161
Temperature Problem	151	151
Contamination /Decontamination Problem	145	145
Failure to Power Up	141	141
Mechanical Problem	135	135
Device Contamination with Chemical or Other Material	127	127
Particulates	110	110
Circuit Failure	106	106
Thermal Decomposition of Device	91	91
Break	68	68
Unexpected Shutdown	61	61
Disconnection	58	58
Display or Visual Feedback Problem	56	56
Product Quality Problem	52	52
Activation Problem	51	51
Pressure Problem	48	48
Defective Device	47	47
Complete Loss of Power	45	45
Unraveled Material	42	42
Sparking	41	41
Obstruction of Flow	41	41
Appropriate Term/Code Not Available	41	41
Peeled/Delaminated	37	37
Decrease in Pressure	36	36
Leak/Splash	35	35
Use of Device Problem	33	33
Material Disintegration	33	33
Detachment of Device or Device Component	32	32
Increase in Pressure	32	32
Crack	31	31
Therapeutic or Diagnostic Output Failure	28	28
Insufficient Heating	28	28
Melted	28	28

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138585	138585
Unspecified Respiratory Problem	34757	34758
Headache	26795	26795
Dizziness	19602	19602
Cancer	18985	18985
Asthma	15229	15230
Dyspnea	12540	12540
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	6831	6831
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	1641	1641
Pneumonia	1544	1544
Heart Failure/Congestive Heart Failure	1388	1388
Pulmonary Dysfunction	1238	1238
Sleep Dysfunction	1219	1219
Epistaxis	1111	1111
Fatigue	1061	1061
Bronchitis	1057	1057
Liver Damage/Dysfunction	1057	1057
Nodule	910	910
Respiratory Failure	657	657
Dry Eye(s)	608	608
Unspecified Eye / Vision Problem	568	568
Stroke/CVA	567	567
Pain	561	561
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	345	345
Nasal Obstruction	339	339
Wheezing	320	320
Myocardial Infarction	319	319
Rash	318	318