TPLC - Total Product Life Cycle

show TPLC since

Device	cable, transducer and electrode, patient, (including connector)
Regulation Description	Patient transducer and electrode cable (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
BAYLIS MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ENERGETIC DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOGG SYSTEM COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	1
IVY BIOMEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC , INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHYSIO-CONTROL, INC.
	SUBSTANTIALLY EQUIVALENT	1
QT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI DRAEGER MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CORERAY TECHNOLOGY., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER PHYSIO-CONTROL
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
XINKANG MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	112	112
Blocked Connection	20	20
Failure to Capture	18	18
Incorrect, Inadequate or Imprecise Result or Readings	11	11
Connection Problem	9	9
Adverse Event Without Identified Device or Use Problem	8	8
No Device Output	5	5
Loose or Intermittent Connection	5	5
Break	4	4
Defective Component	4	4
Defective Device	4	4
Use of Device Problem	4	4
Pacing Intermittently	4	4
Material Separation	4	4
Failure to Read Input Signal	3	3
Therapeutic or Diagnostic Output Failure	3	3
Unable to Obtain Readings	3	3
Detachment of Device or Device Component	3	3
Capturing Problem	2	2
Communication or Transmission Problem	2	2
Physical Resistance/Sticking	2	2
Peeled/Delaminated	2	2
Overheating of Device	2	2
Device Sensing Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Calibration Problem	2	2
Noise, Audible	1	1
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Electrical /Electronic Property Problem	1	1
Display or Visual Feedback Problem	1	1
Corroded	1	1
Human-Device Interface Problem	1	1
Protective Measures Problem	1	1
Loss of Threshold	1	1
Pacing Problem	1	1
Material Protrusion/Extrusion	1	1
Material Deformation	1	1
Component Missing	1	1
Device Difficult to Setup or Prepare	1	1
Unintended Ejection	1	1
Material Discolored	1	1
Intermittent Capture	1	1
Air/Gas in Device	1	1
Patient Device Interaction Problem	1	1
Failure to Sense	1	1
Failure to Transmit Record	1	1
Insufficient Information	1	1
Unintended Movement	1	1
Poor Quality Image	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	160	160
Cardiac Arrest	12	12
No Consequences Or Impact To Patient	12	12
No Known Impact Or Consequence To Patient	9	9
Insufficient Information	6	6
Ventricular Fibrillation	5	5
Bradycardia	4	4
Pericardial Effusion	3	3
Heart Block	3	3
Arrhythmia	2	2
Asystole	2	2
Air Embolism	1	1
Stroke/CVA	1	1
Failure of Implant	1	1
Vascular Dissection	1	1
Burn, Thermal	1	1
Blister	1	1
Localized Skin Lesion	1	1
Cardiac Tamponade	1	1
Burn(s)	1	1
Injury	1	1
Cardiac Perforation	1	1
Discomfort	1	1
No Patient Involvement	1	1
Low Blood Pressure/ Hypotension	1	1