TPLC - Total Product Life Cycle

• Device: cable, transducer and electrode, patient, (including connector)
• Product Code: DSA
• Regulation Number: 870.2900
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ATRILITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AUTHENTIC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CURBELL MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENERGETIC DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC , INC.
	SUBSTANTIALLY EQUIVALENT	1
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
QT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN CORERAY TECHNOLOGY., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
XINKANG MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	15	15
2019	11	11
2020	31	31
2021	9	9
2022	50	50
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	51	51
Failure to Capture	24	24
Adverse Event Without Identified Device or Use Problem	7	7
Connection Problem	5	5
Incorrect, Inadequate or Imprecise Result or Readings	5	5
Material Separation	4	4
Break	4	4
Pacing Intermittently	4	4
No Device Output	3	3
Failure to Read Input Signal	3	3
Use of Device Problem	3	3
Defective Component	3	3
Detachment of Device or Device Component	3	3
Device Operates Differently Than Expected	3	3
Therapeutic or Diagnostic Output Failure	3	3
Output Problem	2	2
Scratched Material	2	2
Physical Resistance/Sticking	2	2
Device Sensing Problem	2	2
Defective Device	2	2
Calibration Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Intermittent Capture	2	2
Unable to Obtain Readings	2	2
Peeled/Delaminated	2	2
Loose or Intermittent Connection	2	2
Incorrect Measurement	1	1
Mechanical Problem	1	1
Poor Quality Image	1	1
Corroded	1	1
Material Discolored	1	1
Display or Visual Feedback Problem	1	1
Failure to Interrogate	1	1
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Overheating of Device	1	1
Over-Sensing	1	1
Pacing Problem	1	1
Loss of or Failure to Bond	1	1
Device Slipped	1	1
Loss of Threshold	1	1
Capturing Problem	1	1
Communication or Transmission Problem	1	1
Component Missing	1	1
Failure to Form Staple	1	1
Improper or Incorrect Procedure or Method	1	1
Device Damaged Prior to Use	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Material Protrusion/Extrusion	1	1
Device Packaging Compromised	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Unintended Movement	1	1
Appropriate Term/Code Not Available	1	1
No Pacing	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	52
No Known Impact Or Consequence To Patient	23	23
No Consequences Or Impact To Patient	13	13
Cardiac Arrest	10	10
No Patient Involvement	7	7
Insufficient Information	3	3
Arrhythmia	1	1
Bradycardia	1	1
Burn(s)	1	1
Vascular Dissection	1	1
No Information	1	1
Pericardial Effusion	1	1
Asystole	1	1
Swelling/ Edema	1	1
Cardiopulmonary Arrest	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Unspecified Infection	1	1
Tissue Damage	1	1
Ventricular Fibrillation	1	1
Cardiac Tamponade	1	1
Discomfort	1	1
Injury	1	1
Cardiac Perforation	1	1
Burn, Thermal	1	1
Complete Heart Block	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare, LLC	III	Jun-26-2019
2	GN Otometrics	II	Sep-23-2019
3	Philips North America, LLC	II	Sep-09-2019
4	Volcano Corp	III	Apr-12-2022