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	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
1. K233415 DELTAWAVE Nasal Pillows System
RESMED CORP
	SUBSTANTIALLY EQUIVALENT	4
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	2
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
WELLELL INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	234102	234104
Contamination	7003	7007
Adverse Event Without Identified Device or Use Problem	2919	2925
Corroded	2466	2466
Nonstandard Device	765	859
Overheating of Device	751	753
No Apparent Adverse Event	642	642
Device Emits Odor	631	647
Insufficient Information	471	472
Patient-Device Incompatibility	404	425
Material Integrity Problem	391	391
Smoking	355	358
Noise, Audible	274	279
Contamination /Decontamination Problem	270	272
Excessive Heating	263	263
Power Problem	249	249
Electrical /Electronic Property Problem	206	206
Fire	206	207
Temperature Problem	192	197
Patient Device Interaction Problem	172	175
Failure to Power Up	171	171
Device Contamination with Chemical or Other Material	159	161
Circuit Failure	148	148
Mechanical Problem	143	143
Thermal Decomposition of Device	133	135
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	62
Product Quality Problem	54	72
Defective Device	53	59
Sparking	51	51
Appropriate Term/Code Not Available	48	49
Obstruction of Flow	45	45
Complete Loss of Power	45	45
Unraveled Material	45	45
Leak/Splash	41	42
Decrease in Pressure	39	39
Environmental Particulates	39	39
Use of Device Problem	37	37
Peeled/Delaminated	37	37
Increase in Pressure	36	36
Crack	34	34
Therapeutic or Diagnostic Output Failure	34	37
Insufficient Heating	33	33
Detachment of Device or Device Component	33	36
Material Disintegration	33	33

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	148504	148533
Unspecified Respiratory Problem	35669	35685
Headache	27369	27409
Dizziness	19987	19994
Cancer	19495	19501
Asthma	15536	15540
Dyspnea	12829	12843
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	6983	6993
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	1682	1687
Pneumonia	1599	1599
Heart Failure/Congestive Heart Failure	1439	1439
Pulmonary Dysfunction	1361	1361
Sleep Dysfunction	1256	1270
Epistaxis	1141	1143
Bronchitis	1121	1123
Fatigue	1104	1112
Liver Damage/Dysfunction	1065	1065
Nodule	951	952
Respiratory Failure	687	687
Dry Eye(s)	617	617
Stroke/CVA	591	591
Unspecified Eye / Vision Problem	590	591
Pain	577	585
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	357	360
Myocardial Infarction	341	341
Nasal Obstruction	340	340
Wheezing	335	336
Fibrosis	331	331