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	1
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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	974	974
Positioning Problem	188	188
Unexpected Shutdown	161	161
Adverse Event Without Identified Device or Use Problem	148	148
Communication or Transmission Problem	123	123
Imprecision	123	123
Noise, Audible	120	120
Failure to Run on Battery	101	101
Failure to Power Up	92	92
Poor Quality Image	88	88
Radiation Output Failure	85	85
Failure to Charge	70	70
Material Deformation	52	52
Incorrect, Inadequate or Imprecise Result or Readings	52	52
Smoking	51	51
Device Sensing Problem	46	46
Failure to Advance	45	45
Physical Resistance/Sticking	42	42
Image Display Error/Artifact	41	41
Use of Device Problem	41	41
Application Program Problem	40	40
Unintended Movement	24	24
Power Problem	23	23
Radiation Output Problem	21	21
No Display/Image	20	20
Mechanical Problem	19	19
Arcing	19	19
Calibration Problem	14	14
Unintended Electrical Shock	12	12
Data Problem	9	9
Electrical /Electronic Property Problem	5	5
Wireless Communication Problem	5	5
Operating System Becomes Nonfunctional	5	5
Connection Problem	4	4
Device Fell	4	4
Computer Operating System Problem	4	4
Unexpected/Unintended Radiation Output	4	4
Output Problem	4	4
Computer Software Problem	4	4
Temperature Problem	4	4
Problem with Software Installation	3	3
Device Displays Incorrect Message	3	3
Therapeutic or Diagnostic Output Failure	3	3
Premature Discharge of Battery	3	3
Overheating of Device	3	3
Unintended System Motion	3	3
Failure to Transmit Record	3	3
Loss of Power	2	2
Display or Visual Feedback Problem	2	2
Unintended Collision	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1435	1435
No Patient Involvement	531	531
No Known Impact Or Consequence To Patient	184	184
Unspecified Tissue Injury	75	75
Unspecified Infection	25	25
Insufficient Information	24	24
Hemorrhage/Bleeding	23	23
Unspecified Nervous System Problem	23	23
Pain	22	22
Post Operative Wound Infection	18	18
Hematoma	17	17
Muscle Weakness	13	13
Cerebrospinal Fluid Leakage	11	11
Numbness	9	9
Urinary Retention	7	7
Nerve Damage	7	7
Thrombosis/Thrombus	6	6
Intracranial Hemorrhage	6	6
Cognitive Changes	6	6
Dysphagia/ Odynophagia	5	5
Bacterial Infection	5	5
Tissue Breakdown	5	5
Ambulation Difficulties	5	5
Dysphasia	5	5
Spinal Column Injury	4	4
Pulmonary Emphysema	4	4
Erosion	4	4
Loss of Range of Motion	4	4
Swelling/ Edema	4	4
Confusion/ Disorientation	3	3
Nervous System Injury	3	3
Bone Fracture(s)	3	3
Paralysis	3	3
Necrosis	3	3
Nicks, cuts or tears of dura or other tissues by device	3	3
Convulsion/Seizure	3	3
Tissue Damage	3	3
Neuropathy	3	3
Dyskinesia	2	2
Cardiac Arrest	2	2
Perforation	2	2
Thrombosis	2	2
Radiation Exposure, Unintended	2	2
Depression	2	2
Impaired Healing	2	2
Paresis	2	2
Abscess	2	2
Cancer	1	1
Paraplegia	1	1
No Consequences Or Impact To Patient	1	1