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
PHILIPS RESPIRONICS
	SUBSTANTIALLY EQUIVALENT	1
1. K233555 AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nas ...
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	5
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	165146	165146
Contamination	3610	3610
Corroded	2459	2459
Adverse Event Without Identified Device or Use Problem	1034	1034
Nonstandard Device	758	758
Patient-Device Incompatibility	390	390
Device Emits Odor	363	363
Smoking	247	247
Insufficient Information	244	244
Overheating of Device	234	234
Material Integrity Problem	228	228
Fire	167	167
Noise, Audible	162	162
Excessive Heating	161	161
Patient Device Interaction Problem	149	149
Contamination /Decontamination Problem	129	129
Particulates	108	108
Temperature Problem	107	107
Mechanical Problem	105	105
Device Contamination with Chemical or Other Material	100	100
Failure to Power Up	99	99
No Apparent Adverse Event	88	88
Thermal Decomposition of Device	62	62
Break	62	62
Disconnection	57	57
Product Quality Problem	52	52
Defective Device	46	46
Power Problem	43	43
Unexpected Shutdown	42	42
Pressure Problem	41	41
Circuit Failure	39	39
Obstruction of Flow	38	38
Peeled/Delaminated	37	37
Activation Problem	36	36
Complete Loss of Power	35	35
Decrease in Pressure	35	35
Appropriate Term/Code Not Available	34	34
Use of Device Problem	32	32
Detachment of Device or Device Component	32	32
Electrical /Electronic Property Problem	32	32
Sparking	31	31
Leak/Splash	29	29
Increase in Pressure	29	29
Therapeutic or Diagnostic Output Failure	28	28
Output Problem	26	26
Melted	26	26
Unraveled Material	25	25
Material Disintegration	24	24
Insufficient Heating	23	23
Connection Problem	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	97862	97862
Unspecified Respiratory Problem	24272	24272
Headache	20604	20604
Dizziness	13564	13564
Cancer	12582	12582
Dyspnea	11918	11918
Asthma	11249	11249
Respiratory Tract Infection	9409	9409
Sore Throat	8066	8066
Cough	7514	7514
Unspecified Kidney or Urinary Problem	7186	7186
Skin Inflammation/ Irritation	5005	5005
Nausea	4839	4839
Inflammation	4292	4292
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3659	3659
Vomiting	3520	3520
Hypersensitivity/Allergic reaction	3329	3329
Unspecified Heart Problem	3104	3104
Dry Mouth	1880	1880
Unspecified Hepatic or Biliary Problem	1858	1858
Insufficient Information	1721	1721
Chronic Obstructive Pulmonary Disease (COPD)	1606	1606
Chest Pain	1503	1503
Sleep Dysfunction	1144	1144
Pneumonia	1087	1087
Epistaxis	1062	1062
Fatigue	960	960
Heart Failure/Congestive Heart Failure	954	954
Liver Damage/Dysfunction	917	917
Nodule	784	784
Bronchitis	758	758
Dry Eye(s)	594	594
Unspecified Eye / Vision Problem	535	535
Pain	533	533
Pulmonary Dysfunction	469	469
Apnea	466	466
Stroke/CVA	456	456
High Blood Pressure/ Hypertension	437	437
Sneezing	429	429
Respiratory Failure	380	380
Burning Sensation	372	372
Swelling/ Edema	343	343
Breast Cancer	337	337
Nasal Obstruction	328	328
Choking	319	319
Cardiovascular Insufficiency	315	315
Rash	303	303
Lymphoma	302	302
Wheezing	285	285
Anxiety	255	255