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
ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIEHM-ORTHOSCAN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	964	964
Positioning Problem	187	187
Unexpected Shutdown	161	161
Adverse Event Without Identified Device or Use Problem	136	136
Imprecision	123	123
Communication or Transmission Problem	120	120
Noise, Audible	119	119
Failure to Run on Battery	101	101
Failure to Power Up	92	92
Poor Quality Image	88	88
Radiation Output Failure	69	69
Failure to Charge	68	68
Material Deformation	51	51
Smoking	48	48
Incorrect, Inadequate or Imprecise Result or Readings	46	46
Device Sensing Problem	45	45
Physical Resistance/Sticking	42	42
Image Display Error/Artifact	42	42
Use of Device Problem	40	40
Application Program Problem	38	38
Failure to Advance	27	27
Unintended Movement	24	24
Power Problem	23	23
Radiation Output Problem	21	21
No Display/Image	20	20
Arcing	19	19
Calibration Problem	14	14
Mechanical Problem	14	14
Unintended Electrical Shock	11	11
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
Unexpected/Unintended Radiation Output	4	4
Computer Operating System Problem	4	4
Output Problem	4	4
Temperature Problem	4	4
Device Displays Incorrect Message	3	3
Problem with Software Installation	3	3
Therapeutic or Diagnostic Output Failure	3	3
Failure to Transmit Record	3	3
Display or Visual Feedback Problem	3	3
Device Fell	3	3
Overheating of Device	3	3
Unintended System Motion	3	3
Computer Software Problem	3	3
Loss of Power	2	2
Unintended Collision	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	1380	1380
No Patient Involvement	531	531
No Known Impact Or Consequence To Patient	184	184
Unspecified Tissue Injury	70	70
Unspecified Infection	23	23
Pain	21	21
Unspecified Nervous System Problem	21	21
Insufficient Information	20	20
Post Operative Wound Infection	19	19
Hemorrhage/Bleeding	18	18
Hematoma	14	14
Muscle Weakness	13	13
Cerebrospinal Fluid Leakage	11	11
Numbness	9	9
Nerve Damage	7	7
Urinary Retention	6	6
Cognitive Changes	6	6
Thrombosis/Thrombus	6	6
Dysphagia/ Odynophagia	5	5
Dysphasia	5	5
Loss of Range of Motion	5	5
Tissue Breakdown	5	5
Bacterial Infection	5	5
Intracranial Hemorrhage	5	5
Swelling/ Edema	4	4
Pulmonary Emphysema	4	4
Spinal Column Injury	4	4
Tissue Damage	3	3
Convulsion/Seizure	3	3
Erosion	3	3
Paralysis	3	3
Confusion/ Disorientation	3	3
Nervous System Injury	3	3
Bone Fracture(s)	3	3
Ambulation Difficulties	3	3
Neuropathy	3	3
Cardiac Arrest	2	2
Dyskinesia	2	2
Thrombosis	2	2
Perforation	2	2
Depression	2	2
Necrosis	2	2
Radiation Exposure, Unintended	2	2
Dyspnea	2	2
Impaired Healing	2	2
Paresis	2	2
Headache	1	1
No Consequences Or Impact To Patient	1	1
Paraplegia	1	1
Cardiovascular Insufficiency	1	1