TPLC - Total Product Life Cycle

show TPLC since

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 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	228404	228404
Contamination	5453	5453
Adverse Event Without Identified Device or Use Problem	2598	2598
Corroded	2464	2464
Nonstandard Device	761	761
Device Emits Odor	517	517
Insufficient Information	440	440
No Apparent Adverse Event	407	407
Patient-Device Incompatibility	401	401
Overheating of Device	395	395
Material Integrity Problem	377	377
Smoking	323	323
Contamination /Decontamination Problem	235	235
Power Problem	217	217
Noise, Audible	214	214
Excessive Heating	211	211
Temperature Problem	169	169
Fire	168	168
Electrical /Electronic Property Problem	168	168
Patient Device Interaction Problem	164	164
Failure to Power Up	154	154
Device Contamination with Chemical or Other Material	138	138
Circuit Failure	114	114
Particulates	111	111
Mechanical Problem	104	104
Thermal Decomposition of Device	98	98
Unexpected Shutdown	70	70
Break	62	62
Display or Visual Feedback Problem	61	61
Activation Problem	58	58
Product Quality Problem	52	52
Defective Device	48	48
Pressure Problem	47	47
Appropriate Term/Code Not Available	46	46
Sparking	46	46
Complete Loss of Power	45	45
Unraveled Material	43	43
Obstruction of Flow	40	40
Decrease in Pressure	38	38
Peeled/Delaminated	37	37
Environmental Particulates	35	35
Leak/Splash	35	35
Increase in Pressure	33	33
Material Disintegration	33	33
Disconnection	33	33
Use of Device Problem	33	33
Crack	31	31
Insufficient Heating	30	30
Melted	27	27
Therapeutic or Diagnostic Output Failure	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143677	143677
Unspecified Respiratory Problem	34892	34892
Headache	26889	26889
Dizziness	19644	19644
Cancer	19082	19082
Asthma	15263	15263
Dyspnea	12604	12604
Unspecified Kidney or Urinary Problem	11138	11138
Respiratory Tract Infection	9818	9818
Sore Throat	8313	8313
Cough	8085	8085
Skin Inflammation/ Irritation	7411	7411
Inflammation	6862	6862
Nausea	6844	6844
Vomiting	5464	5464
Hypersensitivity/Allergic reaction	4994	4994
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4382	4382
Insufficient Information	4209	4209
Unspecified Heart Problem	3874	3874
Unspecified Hepatic or Biliary Problem	3266	3266
Chronic Obstructive Pulmonary Disease (COPD)	2366	2366
Dry Mouth	2002	2002
Chest Pain	1648	1648
Pneumonia	1553	1553
Heart Failure/Congestive Heart Failure	1394	1394
Pulmonary Dysfunction	1242	1242
Sleep Dysfunction	1226	1226
Epistaxis	1120	1120
Fatigue	1066	1066
Bronchitis	1064	1064
Liver Damage/Dysfunction	1059	1059
Nodule	921	921
Respiratory Failure	657	657
Dry Eye(s)	610	610
Stroke/CVA	574	574
Unspecified Eye / Vision Problem	572	572
Pain	563	563
High Blood Pressure/ Hypertension	519	519
Breast Cancer	490	490
Apnea	488	488
Sneezing	460	460
Lymphoma	455	455
Cardiovascular Insufficiency	427	427
Burning Sensation	387	387
Swelling/ Edema	373	373
Choking	347	347
Nasal Obstruction	340	340
Wheezing	323	323
Myocardial Infarction	321	321
Rash	320	320