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	10	10
Data Problem	8	8
Computer Operating System Problem	7	7
Application Program Problem: Medication Error	6	6
No Audible Alarm	5	5
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Output Problem	4	4
Appropriate Term/Code Not Available	4	4
No Device Output	3	3
Erratic or Intermittent Display	3	3
Display or Visual Feedback Problem	3	3
Failure to Transmit Record	2	2
Inaccurate Delivery	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Patient Data Problem	2	2
Measurement System Incompatibility	2	2
Adverse Event Without Identified Device or Use Problem	1	1
Wireless Communication Problem	1	1
Unexpected Shutdown	1	1
Missing Information	1	1
Key or Button Unresponsive/not Working	1	1
Insufficient Information	1	1
Device Sensing Problem	1	1
Inadequate User Interface	1	1
Infusion or Flow Problem	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
Loss of Power	1	1
Material Puncture/Hole	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
Leak/Splash	1	1
Break	1	1
Thermal Decomposition of Device	1	1
Use of Incorrect Control/Treatment Settings	1	1
Failure to Read Input Signal	1	1
Inaccurate Synchronization	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Insufficient Flow or Under Infusion	1	1
No Audible Prompt/Feedback	1	1
Failure to Deliver	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
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
Injury	1	1
Drug Resistant Bacterial Infection	1	1