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
1. K251920 Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Fu ...
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	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	287189	287329
Contamination	13210	13221
Adverse Event Without Identified Device or Use Problem	2929	2929
Corroded	2472	2472
Overheating of Device	2044	2045
No Apparent Adverse Event	720	720
Device Emits Odor	552	552
Insufficient Device Problem Information	473	473
Material Integrity Problem	434	434
Smoking	374	374
Thermal Decomposition of Device	308	308
Excessive Heating	296	296
Power Problem	254	254
Contamination /Decontamination Problem	248	248
Noise, Audible	236	236
Temperature Problem	213	213
Electrical /Electronic Property Problem	208	208
Fire	194	194
Failure to Power Up	170	170
Device Contamination with Chemical or Other Material	165	165
Circuit Failure	159	160
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	52	52
Unraveled Material	52	52
Complete Loss of Power	46	46
Obstruction of Flow	44	44
Pressure Problem	44	44
Disconnection	43	43
Unintended Movement	41	41
Environmental Particulates	39	39
Peeled/Delaminated	37	37
Device Contamination with Body Fluid	36	36
Decrease in Pressure	36	36
Break	34	34
Crack	34	34
Material Disintegration	32	32
Insufficient Heating	32	32
Increase in Pressure	32	32
Contamination of Device Ingredient or Reagent	30	30
Material Split, Cut or Torn	30	30
Detachment of Device or Device Component	29	30
Leak/Splash	29	29
Melted	27	27
Flare or Flash	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202120	202282
Unspecified Respiratory Problem	35785	35804
Headache	27439	27481
Dizziness	20031	20040
Cancer	19553	19561
Asthma	15572	15577
Dyspnea	12895	12909
Unspecified Kidney or Urinary Problem	11363	11365
Eye Irritation	10056	10057
Respiratory Tract Infection	9835	9838
Sore Throat	8435	8442
Cough	8305	8333
Skin Inflammation/ Irritation	7563	7569
Inflammation	7057	7058
Nausea	7000	7011
Vomiting	5608	5612
Hypersensitivity/Allergic reaction	5101	5103
Insufficient Information	4833	4847
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4555	4565
Unspecified Heart Problem	3937	3937
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2478	2479
Dry Mouth	2048	2052
Chest Pain	1687	1693
Pneumonia	1609	1609
Heart Failure/Congestive Heart Failure	1441	1441
Pulmonary Dysfunction	1373	1373
Sinusitis	1366	1367
Sleep Dysfunction	1266	1280
Epistaxis	1146	1148
Bronchitis	1127	1130
Fatigue	1114	1123
Liver Damage/Dysfunction	1064	1064
Nodule	957	959
Respiratory Failure	692	692
Dry Eye(s)	619	619
Stroke/CVA	595	595
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	384	387
Choking	364	367
Myocardial Infarction	347	347
Nasal Obstruction	340	341