TPLC - Total Product Life Cycle

show TPLC since

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	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	242817	242956
Contamination	11261	11276
Adverse Event Without Identified Device or Use Problem	2987	2993
Corroded	2467	2467
Overheating of Device	1851	1853
Nonstandard Device	766	860
No Apparent Adverse Event	666	666
Device Emits Odor	640	656
Insufficient Information	485	486
Patient-Device Incompatibility	404	425
Material Integrity Problem	396	396
Smoking	360	363
Noise, Audible	276	281
Contamination /Decontamination Problem	273	275
Excessive Heating	272	272
Power Problem	250	250
Fire	211	212
Device Contamination with Chemical or Other Material	210	212
Electrical /Electronic Property Problem	210	210
Temperature Problem	202	207
Patient Device Interaction Problem	173	176
Failure to Power Up	172	172
Circuit Failure	157	158
Thermal Decomposition of Device	149	151
Mechanical Problem	143	143
Particulates	113	124
Activation Problem	84	84
Unexpected Shutdown	83	85
Break	78	83
Display or Visual Feedback Problem	64	64
Disconnection	58	59
Pressure Problem	56	65
Product Quality Problem	54	72
Defective Device	53	61
Sparking	52	52
Obstruction of Flow	49	49
Appropriate Term/Code Not Available	48	49
Complete Loss of Power	47	47
Unraveled Material	45	45
Leak/Splash	41	42
Decrease in Pressure	39	39
Environmental Particulates	39	39
Use of Device Problem	37	37
Peeled/Delaminated	37	37
Increase in Pressure	36	36
Unintended Movement	36	36
Detachment of Device or Device Component	36	40
Therapeutic or Diagnostic Output Failure	35	38
Crack	35	35
Material Disintegration	34	34

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	157246	157406
Unspecified Respiratory Problem	35713	35732
Headache	27397	27439
Dizziness	20002	20011
Cancer	19511	19519
Asthma	15544	15549
Dyspnea	12851	12865
Unspecified Kidney or Urinary Problem	11344	11346
Respiratory Tract Infection	9834	9837
Sore Throat	8423	8430
Cough	8266	8294
Skin Inflammation/ Irritation	7552	7558
Inflammation	7045	7046
Nausea	6991	7002
Vomiting	5603	5607
Hypersensitivity/Allergic reaction	5091	5093
Insufficient Information	4764	4778
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4547	4557
Unspecified Heart Problem	3928	3928
Unspecified Hepatic or Biliary Problem	3370	3370
Chronic Obstructive Pulmonary Disease (COPD)	2474	2475
Dry Mouth	2038	2042
Chest Pain	1683	1689
Pneumonia	1604	1604
Heart Failure/Congestive Heart Failure	1440	1440
Pulmonary Dysfunction	1367	1367
Sleep Dysfunction	1259	1273
Epistaxis	1142	1144
Bronchitis	1123	1126
Fatigue	1106	1115
Liver Damage/Dysfunction	1065	1065
Nodule	953	955
Respiratory Failure	688	688
Dry Eye(s)	619	619
Stroke/CVA	594	594
Unspecified Eye / Vision Problem	590	591
Pain	580	588
High Blood Pressure/ Hypertension	539	539
Breast Cancer	518	518
Apnea	514	514
Sneezing	469	472
Lymphoma	467	470
Cardiovascular Insufficiency	434	434
Burning Sensation	392	396
Swelling/ Edema	376	379
Choking	358	361
Myocardial Infarction	342	342
Nasal Obstruction	340	341
Wheezing	335	336
Fibrosis	331	331