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	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
PHILIPS RESPIRONICS
	SUBSTANTIALLY EQUIVALENT	1
1. K233555 AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nas ...
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
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	275759	275899
Contamination	12926	12937
Adverse Event Without Identified Device or Use Problem	2913	2913
Corroded	2470	2470
Overheating of Device	1975	1976
No Apparent Adverse Event	716	716
Device Emits Odor	552	552
Insufficient Device Problem Information	471	471
Material Integrity Problem	416	416
Smoking	370	370
Excessive Heating	294	294
Power Problem	254	254
Contamination /Decontamination Problem	248	248
Noise, Audible	235	235
Electrical /Electronic Property Problem	207	207
Temperature Problem	206	206
Fire	194	194
Thermal Decomposition of Device	171	171
Failure to Power Up	170	170
Device Contamination with Chemical or Other Material	163	163
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	52	52
Unraveled Material	51	51
Appropriate Device Problem Term/Code Not Available	48	48
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
Decrease in Pressure	36	36
Crack	34	34
Break	34	34
Material Disintegration	32	32
Increase in Pressure	32	32
Insufficient Heating	32	32
Contamination of Device Ingredient or Reagent	30	30
Material Split, Cut or Torn	29	29
Leak/Splash	29	29
Detachment of Device or Device Component	27	28
Melted	27	27
Flare or Flash	25	25
Intermittent Loss of Power	24	24

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	190425	190587
Unspecified Respiratory Problem	35771	35790
Headache	27434	27476
Dizziness	20026	20035
Cancer	19552	19560
Asthma	15570	15575
Dyspnea	12889	12903
Unspecified Kidney or Urinary Problem	11362	11364
Eye Irritation	10053	10054
Respiratory Tract Infection	9835	9838
Sore Throat	8433	8440
Cough	8293	8321
Skin Inflammation/ Irritation	7563	7569
Inflammation	7055	7056
Nausea	6998	7009
Vomiting	5607	5611
Hypersensitivity/Allergic reaction	5100	5102
Insufficient Information	4831	4845
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4554	4564
Unspecified Heart Problem	3936	3936
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2478	2479
Dry Mouth	2047	2051
Chest Pain	1686	1692
Pneumonia	1608	1608
Heart Failure/Congestive Heart Failure	1441	1441
Pulmonary Dysfunction	1373	1373
Sinusitis	1352	1353
Sleep Dysfunction	1266	1280
Epistaxis	1145	1147
Bronchitis	1125	1128
Fatigue	1112	1121
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	585	593
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	363	366
Myocardial Infarction	347	347
Nasal Obstruction	340	341