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	3
FISHER & PAYKEL HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	2
FISHER AND PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GENADYNE BIOTECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS RESPIRONICS
	SUBSTANTIALLY EQUIVALENT	1
REMSLEEP HOLDINGS
	SUBSTANTIALLY EQUIVALENT	1
RESMED CORP
	SUBSTANTIALLY EQUIVALENT	4
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	2
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS INC.
	SUBSTANTIALLY EQUIVALENT	3
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
SLEEPNET CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
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4. K241469 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mas ...
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6. K241830 Mojo Full Face Vented Mask; Veraseal 2 Full Face V ...
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	230690	230690
Contamination	5686	5686
Adverse Event Without Identified Device or Use Problem	2695	2695
Corroded	2464	2464
Nonstandard Device	762	762
Device Emits Odor	566	566
Insufficient Information	460	460
No Apparent Adverse Event	443	443
Overheating of Device	418	418
Patient-Device Incompatibility	402	402
Material Integrity Problem	379	379
Smoking	330	330
Noise, Audible	248	248
Contamination /Decontamination Problem	242	242
Power Problem	225	225
Excessive Heating	212	212
Fire	194	194
Electrical /Electronic Property Problem	184	184
Temperature Problem	174	174
Patient Device Interaction Problem	168	168
Failure to Power Up	155	155
Device Contamination with Chemical or Other Material	148	148
Mechanical Problem	141	141
Circuit Failure	117	117
Particulates	111	111
Thermal Decomposition of Device	107	107
Activation Problem	76	76
Unexpected Shutdown	73	73
Break	71	71
Display or Visual Feedback Problem	63	63
Disconnection	58	58
Product Quality Problem	53	53
Pressure Problem	53	53
Defective Device	49	49
Sparking	48	48
Appropriate Term/Code Not Available	47	47
Complete Loss of Power	45	45
Obstruction of Flow	44	44
Unraveled Material	43	43
Leak/Splash	40	40
Decrease in Pressure	38	38
Peeled/Delaminated	37	37
Environmental Particulates	37	37
Increase in Pressure	35	35
Use of Device Problem	35	35
Material Disintegration	33	33
Crack	32	32
Detachment of Device or Device Component	32	32
Insufficient Heating	31	31
Melted	29	29

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	144951	144951
Unspecified Respiratory Problem	35371	35371
Headache	27172	27172
Dizziness	19874	19874
Cancer	19390	19390
Asthma	15461	15461
Dyspnea	12722	12722
Unspecified Kidney or Urinary Problem	11288	11288
Respiratory Tract Infection	9825	9825
Sore Throat	8347	8347
Cough	8169	8169
Skin Inflammation/ Irritation	7503	7503
Inflammation	6969	6969
Nausea	6929	6929
Vomiting	5538	5538
Hypersensitivity/Allergic reaction	5049	5049
Insufficient Information	4512	4512
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4477	4477
Unspecified Heart Problem	3903	3903
Unspecified Hepatic or Biliary Problem	3323	3323
Chronic Obstructive Pulmonary Disease (COPD)	2437	2437
Dry Mouth	2022	2022
Chest Pain	1673	1673
Pneumonia	1588	1588
Heart Failure/Congestive Heart Failure	1424	1424
Pulmonary Dysfunction	1292	1292
Sleep Dysfunction	1241	1241
Epistaxis	1132	1132
Bronchitis	1109	1109
Fatigue	1087	1087
Liver Damage/Dysfunction	1060	1060
Nodule	936	936
Respiratory Failure	676	676
Dry Eye(s)	614	614
Stroke/CVA	585	585
Unspecified Eye / Vision Problem	584	584
Pain	570	570
High Blood Pressure/ Hypertension	529	529
Breast Cancer	510	510
Apnea	502	502
Lymphoma	465	465
Sneezing	463	463
Cardiovascular Insufficiency	429	429
Burning Sensation	388	388
Swelling/ Edema	375	375
Choking	354	354
Nasal Obstruction	340	340
Myocardial Infarction	333	333
Wheezing	330	330
Fibrosis	323	323