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
REMSLEEP HOLDINGS
	SUBSTANTIALLY EQUIVALENT	1
RESMED CORP
	SUBSTANTIALLY EQUIVALENT	3
RESMED LTD
	SUBSTANTIALLY EQUIVALENT	1
RESMED PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
1. K223747 Whitsundays Mask System
2. K230476 Oran Park Mask
3. K234134 AirFit F30i Mask System; AirFit F30i NM Mask Syste ...
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967)
	SUBSTANTIALLY EQUIVALENT	3
1. K223747 Whitsundays Mask System
2. K230476 Oran Park Mask
3. K234134 AirFit F30i Mask System; AirFit F30i NM Mask Syste ...
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	169483	169483
Contamination	3890	3890
Corroded	2461	2461
Adverse Event Without Identified Device or Use Problem	1084	1084
Nonstandard Device	759	759
Patient-Device Incompatibility	390	390
Device Emits Odor	369	369
Smoking	253	253
Insufficient Information	248	248
Material Integrity Problem	242	242
Overheating of Device	238	238
Fire	170	170
Noise, Audible	163	163
Excessive Heating	161	161
Patient Device Interaction Problem	149	149
Contamination /Decontamination Problem	129	129
Temperature Problem	116	116
Mechanical Problem	109	109
Particulates	108	108
Failure to Power Up	104	104
Device Contamination with Chemical or Other Material	101	101
No Apparent Adverse Event	100	100
Thermal Decomposition of Device	68	68
Break	62	62
Disconnection	57	57
Product Quality Problem	52	52
Defective Device	46	46
Unexpected Shutdown	44	44
Power Problem	43	43
Activation Problem	42	42
Pressure Problem	41	41
Obstruction of Flow	40	40
Circuit Failure	39	39
Peeled/Delaminated	37	37
Decrease in Pressure	35	35
Appropriate Term/Code Not Available	35	35
Complete Loss of Power	35	35
Sparking	34	34
Detachment of Device or Device Component	32	32
Use of Device Problem	32	32
Electrical /Electronic Property Problem	32	32
Increase in Pressure	30	30
Unraveled Material	30	30
Leak/Splash	29	29
Therapeutic or Diagnostic Output Failure	28	28
Output Problem	26	26
Melted	26	26
Material Disintegration	25	25
Crack	23	23
Insufficient Heating	23	23

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	98688	98688
Unspecified Respiratory Problem	26487	26487
Headache	21867	21867
Dizziness	14783	14783
Cancer	13502	13502
Dyspnea	12087	12087
Asthma	12001	12001
Respiratory Tract Infection	9585	9585
Sore Throat	8120	8120
Unspecified Kidney or Urinary Problem	7771	7771
Cough	7635	7635
Skin Inflammation/ Irritation	5440	5440
Nausea	5222	5222
Inflammation	4786	4786
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3917	3917
Vomiting	3886	3886
Hypersensitivity/Allergic reaction	3630	3630
Unspecified Heart Problem	3413	3413
Unspecified Hepatic or Biliary Problem	2034	2034
Dry Mouth	1901	1901
Insufficient Information	1834	1834
Chronic Obstructive Pulmonary Disease (COPD)	1711	1711
Chest Pain	1529	1529
Pneumonia	1193	1193
Sleep Dysfunction	1164	1164
Epistaxis	1073	1073
Heart Failure/Congestive Heart Failure	1034	1034
Fatigue	984	984
Liver Damage/Dysfunction	966	966
Bronchitis	825	825
Nodule	811	811
Dry Eye(s)	598	598
Unspecified Eye / Vision Problem	546	546
Pain	539	539
Stroke/CVA	488	488
Pulmonary Dysfunction	485	485
Apnea	470	470
High Blood Pressure/ Hypertension	459	459
Respiratory Failure	453	453
Sneezing	432	432
Burning Sensation	374	374
Breast Cancer	365	365
Cardiovascular Insufficiency	345	345
Swelling/ Edema	345	345
Nasal Obstruction	331	331
Lymphoma	326	326
Choking	324	324
Rash	306	306
Wheezing	294	294
Anxiety	262	262