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
BMC MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FISHER &PAYKEL HEALTHCARE , LTD.
	SUBSTANTIALLY EQUIVALENT	3
FISHER AND PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GENADYNE BIOTECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS RESPIRONICS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESMED CORP
	SUBSTANTIALLY EQUIVALENT	5
RESMED PTY , LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
SLEEPRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WELLELL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	242811	242950
Contamination	11255	11270
Adverse Event Without Identified Device or Use Problem	2959	2965
Corroded	2467	2467
Overheating of Device	1847	1849
Nonstandard Device	765	859
No Apparent Adverse Event	665	665
Device Emits Odor	635	650
Insufficient Information	461	462
Patient-Device Incompatibility	396	417
Material Integrity Problem	396	396
Smoking	354	357
Contamination /Decontamination Problem	273	275
Noise, Audible	272	277
Excessive Heating	272	272
Power Problem	247	247
Electrical /Electronic Property Problem	208	208
Device Contamination with Chemical or Other Material	208	210
Temperature Problem	199	199
Patient Device Interaction Problem	171	174
Failure to Power Up	170	170
Fire	166	167
Circuit Failure	157	158
Thermal Decomposition of Device	145	147
Particulates	113	124
Mechanical Problem	93	93
Activation Problem	84	84
Unexpected Shutdown	83	85
Display or Visual Feedback Problem	63	63
Break	60	65
Sparking	52	52
Product Quality Problem	51	67
Defective Device	49	54
Appropriate Term/Code Not Available	48	49
Complete Loss of Power	47	47
Pressure Problem	46	47
Unraveled Material	45	45
Obstruction of Flow	40	40
Leak/Splash	40	41
Environmental Particulates	39	39
Decrease in Pressure	38	38
Peeled/Delaminated	37	37
Use of Device Problem	36	36
Increase in Pressure	35	35
Crack	35	35
Unintended Movement	35	35
Material Disintegration	34	34
Insufficient Heating	33	33
Contamination of Device Ingredient or Reagent	32	32
Therapeutic or Diagnostic Output Failure	30	31

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	157229	157389
Unspecified Respiratory Problem	35713	35732
Headache	27396	27438
Dizziness	20001	20010
Cancer	19509	19517
Asthma	15543	15548
Dyspnea	12835	12848
Unspecified Kidney or Urinary Problem	11344	11346
Respiratory Tract Infection	9834	9837
Sore Throat	8423	8430
Cough	8266	8294
Skin Inflammation/ Irritation	7552	7558
Inflammation	7045	7046
Nausea	6990	7001
Vomiting	5603	5607
Hypersensitivity/Allergic reaction	5091	5093
Insufficient Information	4761	4775
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4547	4557
Unspecified Heart Problem	3928	3928
Unspecified Hepatic or Biliary Problem	3370	3370
Chronic Obstructive Pulmonary Disease (COPD)	2473	2474
Dry Mouth	2038	2042
Chest Pain	1682	1688
Pneumonia	1602	1602
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1367	1367
Sleep Dysfunction	1259	1273
Epistaxis	1139	1141
Bronchitis	1122	1125
Fatigue	1105	1114
Liver Damage/Dysfunction	1065	1065
Nodule	953	955
Respiratory Failure	686	686
Dry Eye(s)	619	619
Stroke/CVA	594	594
Unspecified Eye / Vision Problem	590	591
Pain	578	585
High Blood Pressure/ Hypertension	538	538
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	357	360
Myocardial Infarction	342	342
Nasal Obstruction	340	341
Wheezing	335	336
Fibrosis	331	331