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
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
1. K203126 S10 Kirra
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	227576	227576
Contamination	4739	4739
Adverse Event Without Identified Device or Use Problem	2567	2567
Corroded	2464	2464
Nonstandard Device	761	761
Insufficient Information	452	452
Device Emits Odor	445	445
Patient-Device Incompatibility	401	401
No Apparent Adverse Event	397	397
Material Integrity Problem	376	376
Overheating of Device	368	368
Smoking	317	317
Noise, Audible	198	198
Excessive Heating	197	197
Power Problem	195	195
Fire	190	190
Contamination /Decontamination Problem	179	179
Patient Device Interaction Problem	165	165
Electrical /Electronic Property Problem	165	165
Temperature Problem	154	154
Failure to Power Up	141	141
Mechanical Problem	138	138
Device Contamination with Chemical or Other Material	129	129
Particulates	111	111
Circuit Failure	107	107
Thermal Decomposition of Device	98	98
Break	69	69
Unexpected Shutdown	65	65
Display or Visual Feedback Problem	59	59
Disconnection	58	58
Product Quality Problem	52	52
Activation Problem	52	52
Pressure Problem	48	48
Defective Device	48	48
Complete Loss of Power	45	45
Unraveled Material	43	43
Sparking	43	43
Obstruction of Flow	42	42
Appropriate Term/Code Not Available	41	41
Peeled/Delaminated	37	37
Decrease in Pressure	37	37
Leak/Splash	36	36
Increase in Pressure	34	34
Environmental Particulates	34	34
Detachment of Device or Device Component	34	34
Material Disintegration	33	33
Use of Device Problem	33	33
Crack	31	31
Melted	28	28
Insufficient Heating	28	28

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	142846	142846
Unspecified Respiratory Problem	34825	34825
Headache	26828	26828
Dizziness	19620	19620
Cancer	19051	19051
Asthma	15252	15252
Dyspnea	12558	12558
Unspecified Kidney or Urinary Problem	11130	11130
Respiratory Tract Infection	9816	9816
Sore Throat	8288	8288
Cough	8054	8054
Skin Inflammation/ Irritation	7404	7404
Inflammation	6857	6857
Nausea	6835	6835
Vomiting	5460	5460
Hypersensitivity/Allergic reaction	4990	4990
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4365	4365
Insufficient Information	4170	4170
Unspecified Heart Problem	3865	3865
Unspecified Hepatic or Biliary Problem	3262	3262
Chronic Obstructive Pulmonary Disease (COPD)	2358	2358
Dry Mouth	1991	1991
Chest Pain	1644	1644
Pneumonia	1550	1550
Heart Failure/Congestive Heart Failure	1392	1392
Pulmonary Dysfunction	1239	1239
Sleep Dysfunction	1221	1221
Epistaxis	1113	1113
Fatigue	1063	1063
Bronchitis	1062	1062
Liver Damage/Dysfunction	1058	1058
Nodule	917	917
Respiratory Failure	658	658
Dry Eye(s)	609	609
Stroke/CVA	572	572
Unspecified Eye / Vision Problem	568	568
Pain	562	562
High Blood Pressure/ Hypertension	519	519
Breast Cancer	490	490
Apnea	483	483
Lymphoma	455	455
Sneezing	453	453
Cardiovascular Insufficiency	427	427
Burning Sensation	382	382
Swelling/ Edema	372	372
Choking	346	346
Nasal Obstruction	339	339
Wheezing	321	321
Myocardial Infarction	320	320
Rash	319	319