TPLC - Total Product Life Cycle

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Device	image-intensified fluoroscopic x-ray system, mobile
Regulation Description	Image-intensified fluoroscopic x-ray system.
Definition	Fluoroscopy of the human body.
Product Code	OXO
Regulation Number	892.1650
Device Class	2

Premarket Reviews
Manufacturer	Decision
GE HUALUN MEDICAL SYSTEMS CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	2
GE OEC MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
HEFEI CHIMED INTELLIGENT MACHINE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIEHM-ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	554	554
Adverse Event Without Identified Device or Use Problem	122	122
Positioning Problem	120	120
Unexpected Shutdown	110	110
Imprecision	92	92
Radiation Output Failure	85	85
Communication or Transmission Problem	70	70
Incorrect, Inadequate or Imprecise Result or Readings	65	66
Noise, Audible	61	61
Poor Quality Image	59	59
Failure to Advance	47	47
Smoking	45	45
Application Program Problem	40	40
Failure to Power Up	38	38
Image Display Error/Artifact	37	37
Failure to Run on Battery	35	35
Device Sensing Problem	32	32
Material Deformation	32	32
Failure to Charge	30	30
Physical Resistance/Sticking	26	26
Use of Device Problem	26	26
Radiation Output Problem	21	21
Mechanical Problem	21	21
Power Problem	16	16
Arcing	14	14
Unintended Movement	14	14
No Display/Image	10	10
Data Problem	9	9
Calibration Problem	9	9
Unintended Electrical Shock	8	8
Computer Operating System Problem	4	4
Unexpected/Unintended Radiation Output	4	4
Failure to Transmit Record	3	3
Device Fell	3	3
Computer Software Problem	3	3
Unintended System Motion	3	3
Connection Problem	3	3
Premature Discharge of Battery	3	3
Output Problem	3	3
Temperature Problem	3	3
Operating System Becomes Nonfunctional	3	3
Problem with Software Installation	2	2
Therapeutic or Diagnostic Output Failure	2	2
Wireless Communication Problem	2	2
Device Damaged Prior to Use	2	2
Appropriate Term/Code Not Available	2	2
Display or Visual Feedback Problem	2	2
Electrical /Electronic Property Problem	2	2
Device Displays Incorrect Message	2	2
Unintended Collision	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1275	1275
Unspecified Tissue Injury	75	76
Unspecified Infection	29	29
Unspecified Nervous System Problem	28	28
Insufficient Information	27	27
Hemorrhage/Bleeding	23	23
Pain	21	21
Hematoma	17	17
Post Operative Wound Infection	16	16
Muscle Weakness	12	12
Cerebrospinal Fluid Leakage	10	10
Neuropathy	7	7
Intracranial Hemorrhage	7	7
Urinary Retention	7	7
Nerve Damage	7	7
Numbness	7	7
Thrombosis/Thrombus	6	6
Dysphasia	5	5
Ambulation Difficulties	5	5
Tissue Breakdown	5	5
Nicks, cuts or tears of dura or other tissues by device	5	5
Bone Fracture(s)	5	5
Cognitive Changes	5	5
Dysphagia/ Odynophagia	5	5
Erosion	4	4
Pulmonary Emphysema	4	4
Bacterial Infection	4	4
Convulsion/Seizure	4	4
Swelling/ Edema	4	4
Loss of Range of Motion	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Nervous System Injury	3	3
Necrosis	3	3
Confusion/ Disorientation	3	3
Paralysis	3	3
Abscess	2	2
Depression	2	2
Spinal Column Injury	2	2
Cardiac Arrest	2	2
Dyskinesia	2	2
Perforation	2	2
Fever	1	1
Visual Disturbances	1	1
Respiratory Tract Infection	1	1
Vomiting	1	1
Discomfort	1	1
Erythema	1	1
Laceration(s)	1	1
Electrolyte Imbalance	1	1
Dyspnea	1	1