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	3
DCSTAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
1. K243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasa ...
PHILIPS RESPIRONICS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESMED CORP
	SUBSTANTIALLY EQUIVALENT	7
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
RESVENT MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
SLEEPRES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOMNETICS INTERNATIONAL, INC. (DBA TRANSCEND INC)
	SUBSTANTIALLY EQUIVALENT	1
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	289327	289467
Contamination	13404	13415
Adverse Event Without Identified Device or Use Problem	2949	2949
Corroded	2472	2472
Overheating of Device	2055	2056
No Apparent Adverse Event	726	726
Device Emits Odor	554	554
Thermal Decomposition of Device	546	546
Insufficient Device Problem Information	479	479
Material Integrity Problem	437	437
Smoking	376	376
Excessive Heating	298	298
Power Problem	254	254
Contamination /Decontamination Problem	249	249
Noise, Audible	236	236
Temperature Problem	215	215
Electrical /Electronic Property Problem	210	210
Fire	195	195
Failure to Power Up	170	170
Device Contamination with Chemical or Other Material	166	166
Circuit Failure	160	161
Mechanical Problem	142	142
Patient-Device Incompatibility	98	98
Activation Problem	83	83
Patient Device Interaction Problem	80	80
Unexpected Shutdown	72	72
Display or Visual Feedback Problem	65	65
Sparking	54	54
Appropriate Device Problem Term/Code Not Available	53	53
Device Contamination with Body Fluid	52	52
Unraveled Material	52	52
Complete Loss of Power	46	46
Obstruction of Flow	46	46
Pressure Problem	44	44
Disconnection	43	43
Unintended Movement	41	41
Environmental Particulates	39	39
Break	37	37
Peeled/Delaminated	37	37
Decrease in Pressure	36	36
Crack	35	35
Insufficient Heating	32	32
Increase in Pressure	32	32
Material Disintegration	32	32
Material Split, Cut or Torn	31	31
Contamination of Device Ingredient or Reagent	30	30
Detachment of Device or Device Component	30	31
Leak/Splash	29	29
Melted	27	27
Flare or Flash	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	204436	204598
Unspecified Respiratory Problem	35792	35811
Headache	27445	27487
Dizziness	20034	20043
Cancer	19554	19562
Asthma	15572	15577
Dyspnea	12903	12917
Unspecified Kidney or Urinary Problem	11363	11365
Eye Irritation	10061	10062
Respiratory Tract Infection	9835	9838
Sore Throat	8439	8446
Cough	8308	8336
Skin Inflammation/ Irritation	7565	7571
Inflammation	7059	7060
Nausea	7005	7016
Vomiting	5611	5615
Hypersensitivity/Allergic reaction	5102	5104
Insufficient Information	4834	4848
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4556	4566
Unspecified Heart Problem	3938	3938
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2478	2479
Dry Mouth	2048	2052
Chest Pain	1688	1694
Pneumonia	1609	1609
Heart Failure/Congestive Heart Failure	1442	1442
Pulmonary Dysfunction	1374	1374
Sinusitis	1372	1373
Sleep Dysfunction	1267	1281
Epistaxis	1147	1149
Bronchitis	1127	1130
Fatigue	1114	1123
Liver Damage/Dysfunction	1064	1064
Nodule	958	960
Respiratory Failure	692	692
Dry Eye(s)	620	620
Stroke/CVA	596	596
Unspecified Eye / Vision Problem	592	593
Pain	586	594
High Blood Pressure/ Hypertension	541	541
Apnea	520	520
Breast Cancer	518	518
Sneezing	469	472
Lymphoma	468	471
Cardiovascular Dysfunction/Insufficiency	434	434
Burning Sensation	394	398
Swelling/ Edema	386	389
Choking	364	367
Myocardial Infarction	347	347
Nasal Obstruction	340	341