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	129	129
Positioning Problem	120	120
Unexpected Shutdown	111	111
Imprecision	92	92
Radiation Output Failure	85	85
Communication or Transmission Problem	70	70
Incorrect, Inadequate or Imprecise Result or Readings	68	69
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
Material Deformation	32	32
Device Sensing Problem	32	32
Failure to Charge	30	30
Physical Resistance/Sticking	26	26
Use of Device Problem	26	26
Mechanical Problem	21	21
Radiation Output Problem	21	21
Power Problem	16	16
Arcing	14	14
Unintended Movement	14	14
No Display/Image	10	10
Calibration Problem	9	9
Data Problem	9	9
Unintended Electrical Shock	8	8
Computer Operating System Problem	4	4
Unexpected/Unintended Radiation Output	4	4
Computer Software Problem	3	3
Premature Discharge of Battery	3	3
Temperature Problem	3	3
Operating System Becomes Nonfunctional	3	3
Output Problem	3	3
Failure to Transmit Record	3	3
Device Fell	3	3
Unintended System Motion	3	3
Connection Problem	3	3
Unintended Collision	2	2
Problem with Software Installation	2	2
Device Damaged Prior to Use	2	2
Therapeutic or Diagnostic Output Failure	2	2
Wireless Communication Problem	2	2
Radiation Overexposure	2	2
Display or Visual Feedback Problem	2	2
Electrical /Electronic Property Problem	2	2
Appropriate Term/Code Not Available	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1277	1277
Unspecified Tissue Injury	79	80
Unspecified Infection	31	31
Unspecified Nervous System Problem	31	31
Insufficient Information	30	30
Hemorrhage/Bleeding	24	24
Pain	22	22
Hematoma	19	19
Post Operative Wound Infection	16	16
Muscle Weakness	12	12
Cerebrospinal Fluid Leakage	10	10
Neuropathy	7	7
Dysphasia	7	7
Numbness	7	7
Urinary Retention	7	7
Nerve Damage	7	7
Intracranial Hemorrhage	7	7
Cognitive Changes	6	6
Thrombosis/Thrombus	6	6
Dysphagia/ Odynophagia	5	5
Ambulation Difficulties	5	5
Swelling/ Edema	5	5
Tissue Breakdown	5	5
Nicks, cuts or tears of dura or other tissues by device	5	5
Convulsion/Seizure	5	5
Bone Fracture(s)	5	5
Bacterial Infection	4	4
Loss of Range of Motion	4	4
Erosion	4	4
Paralysis	4	4
Pulmonary Emphysema	4	4
Confusion/ Disorientation	3	3
Necrosis	3	3
Nervous System Injury	3	3
Abscess	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Fever	2	2
Headache	2	2
Spinal Column Injury	2	2
Cardiac Arrest	2	2
Dyskinesia	2	2
Vomiting	2	2
Depression	2	2
Perforation	2	2
Cardiovascular Insufficiency	2	2
Paresis	2	2
Urinary Tract Infection	2	2
Meningitis	1	1
Paraplegia	1	1
Cancer	1	1