TPLC - Total Product Life Cycle

• 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	4
BARCO NV
	SUBSTANTIALLY EQUIVALENT	1
EIZO GMBH
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIVANOVA DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDUSA MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
PERKINS HEALTHCARE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
	SUBSTANTIALLY EQUIVALENT	1
SHENYANG TORCH-BIGTIDE DIGITAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SORIN GROUP DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	2
ST. JUDE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
VIOS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZOLL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2014	11	11
2015	15	15
2016	6	6
2017	10	10
2018	3	3
2019	29	29
2020	22	22
2021	6	6
2022	2	2
2023	17	17
2024	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	16	16
Data Problem	10	10
Application Program Problem: Medication Error	8	8
Computer Operating System Problem	7	7
Device Operates Differently Than Expected	6	6
No Audible Alarm	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Improper or Incorrect Procedure or Method	4	4
Output Problem	4	4
Appropriate Term/Code Not Available	4	4
Patient Data Problem	3	3
Erratic or Intermittent Display	3	3
Inaccurate Delivery	3	3
No Device Output	3	3
Display or Visual Feedback Problem	3	3
Application Program Problem: Dose Calculation Error	2	2
Fracture	2	2
Unsealed Device Packaging	2	2
Tear, Rip or Hole in Device Packaging	2	2
Low Readings	2	2
Failure to Disconnect	2	2
Device Displays Incorrect Message	2	2
Device Alarm System	2	2
Failure to Transmit Record	2	2
Use of Device Problem	2	2
Insufficient Flow or Under Infusion	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Wireless Communication Problem	2	2
Measurement System Incompatibility	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Loss of Data	2	2
Device Packaging Compromised	2	2
Device Sensing Problem	1	1
Electrical Shorting	1	1
Human Factors Issue	1	1
Improper Alarm	1	1
Inadequate User Interface	1	1
Infusion or Flow Problem	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Pressure Problem	1	1
Unexpected Shutdown	1	1
Missing Information	1	1
Key or Button Unresponsive/not Working	1	1
Insufficient Information	1	1
No Audible Prompt/Feedback	1	1
Failure to Deliver	1	1
Application Program Problem	1	1
Communication or Transmission Problem	1	1
Defective Device	1	1
Split	1	1
Loss of Power	1	1
Failure to Power Up	1	1
Material Puncture/Hole	1	1
Material Separation	1	1
Failure to Read Input Signal	1	1
Smoking	1	1
Inaccurate Synchronization	1	1
Telemetry Discrepancy	1	1
Image Display Error/Artifact	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Break	1	1
Thermal Decomposition of Device	1	1
Burst Container or Vessel	1	1
Charred	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	42	42
No Clinical Signs, Symptoms or Conditions	40	40
No Consequences Or Impact To Patient	16	16
No Patient Involvement	12	12
Death	6	6
Insufficient Information	3	3
Injury	3	3
No Information	2	2
No Code Available	2	2
Overdose	2	2
Septic Shock	1	1
Cardiogenic Shock	1	1
Complaint, Ill-Defined	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Myocardial Infarction	1	1
Multiple Organ Failure	1	1
Drug Resistant Bacterial Infection	1	1
Low Oxygen Saturation	1	1
Missed Dose	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BARCO NV	II	Sep-29-2022
2	GE Healthcare, LLC	II	Jun-13-2022
3	GE Healthcare, LLC	II	Mar-16-2022
4	Philips Healthcare Inc.	II	Aug-31-2011
5	Philips Healthcare Inc.	II	Nov-18-2010
6	Philips Healthcare Inc.	II	Nov-24-2009
7	Philips Healthcare Inc.	II	Jul-07-2009
8	Philips Healthcare Inc.	II	May-27-2009
9	Spacelabs Healthcare, Incorporated	II	Nov-02-2010
10	Spacelabs Healthcare, Incorporated	II	Jan-19-2010
11	Spacelabs Healthcare, Llc	II	Dec-14-2010