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
No Audible Alarm	5	5
Application Program Problem: Medication Error	5	5
Data Problem	5	5
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Computer Operating System Problem	3	3
Erratic or Intermittent Display	3	3
No Device Output	3	3
Output Problem	2	2
Inaccurate Delivery	2	2
Appropriate Term/Code Not Available	2	2
Display or Visual Feedback Problem	2	2
Leak/Splash	1	1
Failure to Read Input Signal	1	1
Unexpected Shutdown	1	1
Break	1	1
Communication or Transmission Problem	1	1
Image Display Error/Artifact	1	1
Material Puncture/Hole	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Deliver	1	1
Key or Button Unresponsive/not Working	1	1
Inaccurate Synchronization	1	1
Thermal Decomposition of Device	1	1
Application Program Problem: Dose Calculation Error	1	1
Insufficient Flow or Under Infusion	1	1
Infusion or Flow Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Labelling, Instructions for Use or Training Problem	1	1
Device Sensing Problem	1	1
Protective Measures Problem	1	1
Loss of Power	1	1
Improper or Incorrect Procedure or Method	1	1
Inadequate User Interface	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	7	7
No Patient Involvement	5	5
Insufficient Information	3	3
No Consequences Or Impact To Patient	3	3
Drug Resistant Bacterial Infection	1	1