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 LIMITED
	SUBSTANTIALLY EQUIVALENT	1
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	4
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	2
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
WELLELL INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	234099	234101
Contamination	7000	7004
Adverse Event Without Identified Device or Use Problem	2904	2910
Corroded	2466	2466
Nonstandard Device	764	858
Overheating of Device	750	752
No Apparent Adverse Event	642	642
Device Emits Odor	629	645
Insufficient Information	455	456
Patient-Device Incompatibility	403	424
Material Integrity Problem	391	391
Smoking	354	357
Noise, Audible	271	276
Contamination /Decontamination Problem	270	272
Excessive Heating	263	263
Power Problem	248	248
Electrical /Electronic Property Problem	205	205
Temperature Problem	191	196
Fire	183	184
Failure to Power Up	171	171
Patient Device Interaction Problem	170	173
Device Contamination with Chemical or Other Material	157	159
Circuit Failure	148	148
Thermal Decomposition of Device	130	132
Particulates	113	124
Mechanical Problem	108	108
Activation Problem	84	84
Unexpected Shutdown	81	83
Break	65	70
Display or Visual Feedback Problem	63	63
Product Quality Problem	53	69
Pressure Problem	52	59
Defective Device	52	58
Sparking	51	51
Appropriate Term/Code Not Available	48	49
Unraveled Material	45	45
Complete Loss of Power	45	45
Obstruction of Flow	41	41
Leak/Splash	40	41
Decrease in Pressure	39	39
Environmental Particulates	39	39
Peeled/Delaminated	37	37
Use of Device Problem	36	36
Increase in Pressure	35	35
Crack	34	34
Disconnection	33	34
Material Disintegration	33	33
Insufficient Heating	33	33
Melted	31	32
Therapeutic or Diagnostic Output Failure	31	34

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	148501	148530
Unspecified Respiratory Problem	35669	35685
Headache	27368	27408
Dizziness	19986	19993
Cancer	19495	19501
Asthma	15535	15539
Dyspnea	12824	12838
Unspecified Kidney or Urinary Problem	11339	11339
Respiratory Tract Infection	9834	9836
Sore Throat	8411	8418
Cough	8248	8276
Skin Inflammation/ Irritation	7548	7552
Inflammation	7040	7041
Nausea	6982	6992
Vomiting	5597	5601
Hypersensitivity/Allergic reaction	5087	5089
Insufficient Information	4706	4719
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4533	4543
Unspecified Heart Problem	3924	3924
Unspecified Hepatic or Biliary Problem	3366	3366
Chronic Obstructive Pulmonary Disease (COPD)	2468	2469
Dry Mouth	2037	2040
Chest Pain	1681	1686
Pneumonia	1598	1598
Heart Failure/Congestive Heart Failure	1439	1439
Pulmonary Dysfunction	1361	1361
Sleep Dysfunction	1256	1270
Epistaxis	1141	1143
Bronchitis	1120	1122
Fatigue	1103	1111
Liver Damage/Dysfunction	1065	1065
Nodule	951	952
Respiratory Failure	685	685
Dry Eye(s)	617	617
Stroke/CVA	591	591
Unspecified Eye / Vision Problem	590	591
Pain	575	582
High Blood Pressure/ Hypertension	537	537
Breast Cancer	517	517
Apnea	513	513
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	391	395
Swelling/ Edema	375	378
Choking	356	359
Myocardial Infarction	341	341
Nasal Obstruction	340	340
Wheezing	335	336
Fibrosis	331	331