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	4
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	2
1. K223747 Whitsundays Mask System
2. K230476 Oran Park Mask
3. K234134 AirFit F30i Mask System; AirFit F30i NM Mask Syste ...
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
1. K223747 Whitsundays Mask System
2. K230476 Oran Park Mask
3. K234134 AirFit F30i Mask System; AirFit F30i NM Mask Syste ...
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	228407	228407
Contamination	5456	5456
Adverse Event Without Identified Device or Use Problem	2613	2613
Corroded	2464	2464
Nonstandard Device	762	762
Device Emits Odor	519	519
Insufficient Information	456	456
No Apparent Adverse Event	407	407
Patient-Device Incompatibility	402	402
Overheating of Device	396	396
Material Integrity Problem	377	377
Smoking	324	324
Contamination /Decontamination Problem	235	235
Power Problem	218	218
Noise, Audible	217	217
Excessive Heating	211	211
Fire	191	191
Temperature Problem	170	170
Electrical /Electronic Property Problem	169	169
Patient Device Interaction Problem	166	166
Failure to Power Up	154	154
Device Contamination with Chemical or Other Material	140	140
Mechanical Problem	139	139
Circuit Failure	114	114
Particulates	111	111
Thermal Decomposition of Device	101	101
Break	71	71
Unexpected Shutdown	70	70
Display or Visual Feedback Problem	62	62
Activation Problem	58	58
Disconnection	58	58
Product Quality Problem	53	53
Pressure Problem	50	50
Defective Device	49	49
Appropriate Term/Code Not Available	46	46
Sparking	46	46
Complete Loss of Power	45	45
Obstruction of Flow	44	44
Unraveled Material	43	43
Decrease in Pressure	38	38
Peeled/Delaminated	37	37
Leak/Splash	36	36
Environmental Particulates	35	35
Increase in Pressure	34	34
Use of Device Problem	34	34
Detachment of Device or Device Component	34	34
Material Disintegration	33	33
Crack	31	31
Insufficient Heating	30	30
Therapeutic or Diagnostic Output Failure	29	29

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143680	143680
Unspecified Respiratory Problem	34892	34892
Headache	26890	26890
Dizziness	19645	19645
Cancer	19082	19082
Asthma	15264	15264
Dyspnea	12609	12609
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	6845	6845
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	1649	1649
Pneumonia	1554	1554
Heart Failure/Congestive Heart Failure	1394	1394
Pulmonary Dysfunction	1242	1242
Sleep Dysfunction	1226	1226
Epistaxis	1120	1120
Fatigue	1067	1067
Bronchitis	1065	1065
Liver Damage/Dysfunction	1059	1059
Nodule	921	921
Respiratory Failure	659	659
Dry Eye(s)	610	610
Stroke/CVA	574	574
Unspecified Eye / Vision Problem	572	572
Pain	565	565
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	348	348
Nasal Obstruction	340	340
Wheezing	323	323
Myocardial Infarction	321	321
Rash	320	320