TPLC - Total Product Life Cycle

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Device	display, cathode-ray tube, medical
Product Code	DXJ
Regulation Number	870.2450
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARCO N.V.
	SUBSTANTIALLY EQUIVALENT	1
LIVANOVA DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	2
SHENYANG TORCH-BIGTIDE DIGITAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
VIOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Data Problem	8	8
Computer Operating System Problem	7	7
Application Program Problem: Medication Error	6	6
Appropriate Term/Code Not Available	4	4
Output Problem	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
No Audible Alarm	3	3
Display or Visual Feedback Problem	3	3
Inaccurate Delivery	3	3
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
No Display/Image	2	2
Failure to Transmit Record	2	2
Measurement System Incompatibility	2	2
Improper or Incorrect Procedure or Method	2	2
Insufficient Flow or Under Infusion	2	2
Patient Data Problem	2	2
Wireless Communication Problem	1	1
Unexpected Shutdown	1	1
Missing Information	1	1
Key or Button Unresponsive/not Working	1	1
No Audible Prompt/Feedback	1	1
Failure to Deliver	1	1
Failure to Read Input Signal	1	1
Inaccurate Synchronization	1	1
Use of Device Problem	1	1
Application Program Problem: Dose Calculation Error	1	1
Image Display Error/Artifact	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loss of Power	1	1
Material Puncture/Hole	1	1
Break	1	1
Thermal Decomposition of Device	1	1
Erratic or Intermittent Display	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Information	1	1
Tear, Rip or Hole in Device Packaging	1	1
Defective Device	1	1
Device Displays Incorrect Message	1	1
Application Program Problem	1	1
Communication or Transmission Problem	1	1
Device Markings/Labelling Problem	1	1
Device Sensing Problem	1	1
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	25	25
No Clinical Signs, Symptoms or Conditions	23	23
No Patient Involvement	8	8
No Consequences Or Impact To Patient	7	7
Insufficient Information	3	3
Death	2	2
Injury	2	2
Drug Resistant Bacterial Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Overdose	1	1
Complaint, Ill-Defined	1	1