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
1. K243583 F&P Nova Nasal Mask
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
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	259484	259625
Contamination	12721	12736
Adverse Event Without Identified Device or Use Problem	3043	3049
Corroded	2467	2467
Overheating of Device	1925	1927
Nonstandard Device	769	863
No Apparent Adverse Event	706	706
Device Emits Odor	661	677
Insufficient Information	495	496
Patient-Device Incompatibility	404	425
Material Integrity Problem	403	403
Smoking	371	374
Excessive Heating	281	281
Noise, Audible	277	282
Contamination /Decontamination Problem	275	277
Power Problem	252	252
Fire	216	217
Device Contamination with Chemical or Other Material	213	215
Electrical /Electronic Property Problem	211	211
Temperature Problem	204	209
Patient Device Interaction Problem	175	178
Failure to Power Up	172	172
Circuit Failure	157	158
Thermal Decomposition of Device	156	158
Mechanical Problem	143	143
Particulates	112	123
Unexpected Shutdown	87	89
Activation Problem	84	84
Break	78	83
Display or Visual Feedback Problem	65	65
Disconnection	58	59
Product Quality Problem	58	76
Pressure Problem	56	65
Defective Device	56	64
Sparking	53	53
Unraveled Material	49	49
Obstruction of Flow	49	49
Complete Loss of Power	48	48
Appropriate Term/Code Not Available	48	49
Decrease in Pressure	42	42
Leak/Splash	41	42
Unintended Movement	39	39
Environmental Particulates	39	39
Use of Device Problem	38	38
Peeled/Delaminated	37	37
Increase in Pressure	37	37
Crack	36	36
Detachment of Device or Device Component	36	40
Material Disintegration	36	36
Therapeutic or Diagnostic Output Failure	36	39

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	173997	174159
Unspecified Respiratory Problem	35760	35779
Headache	27421	27463
Dizziness	20019	20028
Cancer	19543	19551
Asthma	15568	15573
Dyspnea	12868	12882
Unspecified Kidney or Urinary Problem	11358	11360
Respiratory Tract Infection	9834	9837
Sore Throat	8428	8435
Cough	8278	8306
Skin Inflammation/ Irritation	7562	7568
Inflammation	7052	7053
Nausea	6994	7005
Vomiting	5605	5609
Hypersensitivity/Allergic reaction	5097	5099
Insufficient Information	4814	4828
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4552	4562
Unspecified Heart Problem	3935	3935
Unspecified Hepatic or Biliary Problem	3375	3375
Chronic Obstructive Pulmonary Disease (COPD)	2476	2477
Dry Mouth	2042	2046
Chest Pain	1686	1692
Pneumonia	1607	1607
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1372	1372
Sleep Dysfunction	1265	1279
Epistaxis	1142	1144
Bronchitis	1125	1128
Fatigue	1110	1119
Liver Damage/Dysfunction	1065	1065
Nodule	955	957
Respiratory Failure	691	691
Dry Eye(s)	619	619
Stroke/CVA	595	595
Unspecified Eye / Vision Problem	591	592
Pain	580	588
High Blood Pressure/ Hypertension	540	540
Breast Cancer	518	518
Apnea	516	516
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	393	397
Swelling/ Edema	382	385
Choking	361	364
Myocardial Infarction	345	345
Nasal Obstruction	340	341
Wheezing	336	337
Fibrosis	332	332