TPLC - Total Product Life Cycle

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Device	ventilator, non-continuous (respirator)
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	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	3
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
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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2. K203601 Innova Nasal Non-Vented Mask
3. K211274 iQ 2 Nasal Mask, Phantom 2 Nasal Mask
4. K241469 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mas ...
5. K241661 Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face ...
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Degraded	184792	184793
Contamination	4089	4089
Corroded	2461	2461
Adverse Event Without Identified Device or Use Problem	1587	1587
Nonstandard Device	759	759
Patient-Device Incompatibility	400	400
Device Emits Odor	382	382
Insufficient Information	358	358
Material Integrity Problem	325	325
Overheating of Device	303	303
Smoking	298	298
No Apparent Adverse Event	198	198
Fire	181	181
Excessive Heating	179	179
Noise, Audible	178	178
Patient Device Interaction Problem	151	151
Contamination /Decontamination Problem	141	141
Failure to Power Up	131	131
Mechanical Problem	128	128
Temperature Problem	123	123
Power Problem	113	113
Device Contamination with Chemical or Other Material	109	109
Particulates	109	109
Thermal Decomposition of Device	74	74
Break	64	64
Circuit Failure	59	59
Disconnection	57	57
Unexpected Shutdown	57	57
Product Quality Problem	52	52
Activation Problem	51	51
Electrical /Electronic Property Problem	50	50
Defective Device	46	46
Pressure Problem	44	44
Complete Loss of Power	40	40
Appropriate Term/Code Not Available	40	40
Obstruction of Flow	40	40
Display or Visual Feedback Problem	39	39
Sparking	38	38
Peeled/Delaminated	37	37
Unraveled Material	35	35
Decrease in Pressure	35	35
Use of Device Problem	33	33
Leak/Splash	33	33
Detachment of Device or Device Component	32	32
Increase in Pressure	31	31
Material Disintegration	31	31
Therapeutic or Diagnostic Output Failure	28	28
Melted	27	27
Output Problem	26	26
Crack	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	104911	104911
Unspecified Respiratory Problem	31518	31519
Headache	24890	24890
Dizziness	17742	17742
Cancer	17004	17004
Asthma	13959	13960
Dyspnea	12403	12403
Unspecified Kidney or Urinary Problem	9840	9840
Respiratory Tract Infection	9767	9767
Sore Throat	8231	8231
Cough	7914	7914
Skin Inflammation/ Irritation	6629	6629
Nausea	6206	6206
Inflammation	6034	6035
Vomiting	4841	4841
Hypersensitivity/Allergic reaction	4494	4494
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4213	4213
Unspecified Heart Problem	3749	3749
Insufficient Information	3267	3267
Unspecified Hepatic or Biliary Problem	2773	2773
Chronic Obstructive Pulmonary Disease (COPD)	2081	2081
Dry Mouth	1958	1958
Chest Pain	1611	1611
Pneumonia	1407	1407
Heart Failure/Congestive Heart Failure	1248	1248
Sleep Dysfunction	1194	1194
Epistaxis	1100	1100
Liver Damage/Dysfunction	1039	1039
Fatigue	1036	1036
Bronchitis	969	969
Pulmonary Dysfunction	891	891
Nodule	880	880
Dry Eye(s)	605	605
Respiratory Failure	578	578
Unspecified Eye / Vision Problem	563	563
Pain	556	556
Stroke/CVA	543	543
High Blood Pressure/ Hypertension	492	492
Apnea	480	480
Sneezing	442	442
Breast Cancer	441	441
Lymphoma	412	412
Cardiovascular Insufficiency	406	406
Burning Sensation	377	377
Swelling/ Edema	361	361
Nasal Obstruction	337	337
Choking	337	337
Rash	315	315
Wheezing	314	314
Atrial Fibrillation	286	286