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
APK TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ATRILITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
AUTHENTIC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION 2200 INC.
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION 303, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURBELL MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENERGETIC DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRAL PROCESS SAS
	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
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
2017	5	5
2018	15	15
2019	11	11
2020	31	31
2021	9	9
2022	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	20	20
Failure to Capture	16	16
Adverse Event Without Identified Device or Use Problem	6	6
Incorrect, Inadequate or Imprecise Resultor Readings	5	5
Material Separation	4	4
Break	4	4
Pacing Intermittently	4	4
Connection Problem	4	4
Detachment of Device or Device Component	3	3
Device Operates Differently Than Expected	3	3
Therapeutic or Diagnostic Output Failure	3	3
Peeled/Delaminated	3	3
No Device Output	3	3
Loose or Intermittent Connection	3	3
Defective Component	3	3
Defective Device	2	2
Unable to Obtain Readings	2	2
Inadequacy of Device Shape and/or Size	2	2
Intermittent Capture	2	2
Output Problem	2	2
Scratched Material	2	2
Device Damaged Prior to Use	2	2
Physical Resistance/Sticking	2	2
Unintended Movement	1	1
No Pacing	1	1
Patient Device Interaction Problem	1	1
Device Packaging Compromised	1	1
Device Sensing Problem	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Material Protrusion/Extrusion	1	1
Incorrect Measurement	1	1
Corroded	1	1
Material Discolored	1	1
Display or Visual Feedback Problem	1	1
Failure to Interrogate	1	1
Overheating of Device	1	1
Over-Sensing	1	1
Pacing Problem	1	1
Device Difficult to Setup or Prepare	1	1
Product Quality Problem	1	1
Device Slipped	1	1
Loss of Threshold	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of or Failure to Bond	1	1
Failure to Read Input Signal	1	1
Device Displays Incorrect Message	1	1
Capturing Problem	1	1
Communication or Transmission Problem	1	1
Component Missing	1	1
Out-Of-Box Failure	1	1
Failure to Form Staple	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	24	24
No Clinical Signs, Symptoms or Conditions	16	16
No Consequences Or Impact To Patient	13	13
No Patient Involvement	10	10
Cardiac Arrest	8	8
Insufficient Information	3	3
Bradycardia	2	2
Arrhythmia	1	1
Vascular Dissection	1	1
No Information	1	1
Pericardial Effusion	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