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	5
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	2
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESMED, LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	7
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
SLEEPRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K251770 SleepRes PAP System
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	245732	245872
Contamination	11296	11311
Adverse Event Without Identified Device or Use Problem	3008	3014
Corroded	2467	2467
Overheating of Device	1863	1865
Nonstandard Device	767	861
No Apparent Adverse Event	676	676
Device Emits Odor	649	665
Insufficient Information	485	486
Patient-Device Incompatibility	404	425
Material Integrity Problem	399	399
Smoking	363	366
Noise, Audible	276	281
Contamination /Decontamination Problem	273	275
Excessive Heating	273	273
Power Problem	251	251
Fire	213	214
Electrical /Electronic Property Problem	210	210
Device Contamination with Chemical or Other Material	210	212
Temperature Problem	203	208
Patient Device Interaction Problem	173	176
Failure to Power Up	172	172
Circuit Failure	157	158
Thermal Decomposition of Device	151	153
Mechanical Problem	143	143
Particulates	113	124
Activation Problem	84	84
Unexpected Shutdown	83	85
Break	78	83
Display or Visual Feedback Problem	64	64
Disconnection	58	59
Pressure Problem	56	65
Product Quality Problem	54	72
Defective Device	53	61
Sparking	52	52
Obstruction of Flow	49	49
Appropriate Term/Code Not Available	48	49
Complete Loss of Power	47	47
Unraveled Material	47	47
Leak/Splash	41	42
Decrease in Pressure	39	39
Environmental Particulates	39	39
Peeled/Delaminated	37	37
Use of Device Problem	37	37
Increase in Pressure	36	36
Unintended Movement	36	36
Material Disintegration	36	36
Detachment of Device or Device Component	36	40
Therapeutic or Diagnostic Output Failure	35	38
Crack	35	35

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160163	160324
Unspecified Respiratory Problem	35732	35751
Headache	27407	27449
Dizziness	20009	20018
Cancer	19519	19527
Asthma	15556	15561
Dyspnea	12854	12868
Unspecified Kidney or Urinary Problem	11350	11352
Respiratory Tract Infection	9834	9837
Sore Throat	8425	8432
Cough	8270	8298
Skin Inflammation/ Irritation	7554	7560
Inflammation	7052	7053
Nausea	6992	7003
Vomiting	5604	5608
Hypersensitivity/Allergic reaction	5095	5097
Insufficient Information	4781	4795
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4548	4558
Unspecified Heart Problem	3930	3930
Unspecified Hepatic or Biliary Problem	3372	3372
Chronic Obstructive Pulmonary Disease (COPD)	2475	2476
Dry Mouth	2039	2043
Chest Pain	1684	1690
Pneumonia	1605	1605
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1368	1368
Sleep Dysfunction	1261	1275
Epistaxis	1142	1144
Bronchitis	1125	1128
Fatigue	1107	1116
Liver Damage/Dysfunction	1065	1065
Nodule	953	955
Respiratory Failure	688	688
Dry Eye(s)	619	619
Stroke/CVA	594	594
Unspecified Eye / Vision Problem	590	591
Pain	580	588
High Blood Pressure/ Hypertension	539	539
Breast Cancer	518	518
Apnea	514	514
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	393	397
Swelling/ Edema	377	380
Choking	360	363
Myocardial Infarction	343	343
Nasal Obstruction	340	341
Wheezing	335	336
Fibrosis	332	332