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
LIVANOVA DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHENYANG TORCH-BIGTIDE DIGITAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	11	11
Data Problem	8	8
Computer Operating System Problem	7	7
No Audible Alarm	6	6
Application Program Problem: Medication Error	6	6
Appropriate Term/Code Not Available	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Output Problem	4	4
Display or Visual Feedback Problem	3	3
Erratic or Intermittent Display	3	3
No Device Output	3	3
Protective Measures Problem	2	2
Inaccurate Delivery	2	2
Failure to Transmit Record	2	2
Therapeutic or Diagnostic Output Failure	2	2
Measurement System Incompatibility	2	2
Patient Data Problem	2	2
Application Program Problem	1	1
Material Puncture/Hole	1	1
Wireless Communication Problem	1	1
Insufficient Information	1	1
Inaccurate Synchronization	1	1
Image Display Error/Artifact	1	1
Use of Device Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Sensing Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Missing Information	1	1
Leak/Splash	1	1
Inadequate User Interface	1	1
Unexpected Shutdown	1	1
Failure to Read Input Signal	1	1
Break	1	1
Communication or Transmission Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
No Audible Prompt/Feedback	1	1
Key or Button Unresponsive/not Working	1	1
Failure to Deliver	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Flow or Under Infusion	1	1
Infusion or Flow Problem	1	1
Thermal Decomposition of Device	1	1
Application Program Problem: Dose Calculation Error	1	1
Defective Device	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Power	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	43	43
No Known Impact Or Consequence To Patient	25	25
No Patient Involvement	8	8
No Consequences Or Impact To Patient	7	7
Insufficient Information	3	3
Death	2	2
Hypersensitivity/Allergic reaction	1	1
Drug Resistant Bacterial Infection	1	1
Injury	1	1