TPLC - Total Product Life Cycle

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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	2
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CURBELL MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DRÄGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
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
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORANTECH, 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	2
SHENZHEN CORERAY TECHNOLOGY, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER PHYSIO-CONTROL
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
XINKANG MEDICAL INSTRUMENT CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	178	179
Failure to Capture	24	24
Blocked Connection	20	20
Connection Problem	12	12
Incorrect, Inadequate or Imprecise Result or Readings	12	13
Loose or Intermittent Connection	10	10
Adverse Event Without Identified Device or Use Problem	9	9
No Device Output	6	6
Use of Device Problem	4	4
Pacing Intermittently	4	4
Incorrect Measurement	4	4
Communication or Transmission Problem	3	3
Failure to Sense	3	3
Failure to Read Input Signal	2	2
Mechanical Problem	2	2
Capturing Problem	2	2
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Patient Device Interaction Problem	2	2
Intermittent Capture	2	2
Device Sensing Problem	2	2
Imprecise or Erratic Results	2	2
Calibration Problem	2	2
Material Separation	2	2
Noise, Audible	1	1
Electrical /Electronic Property Problem	1	1
No Pacing	1	1
Overheating of Device	1	1
Human-Device Interface Problem	1	1
Nonstandard Device	1	1
Device Operates Differently Than Expected	1	1
Loss of Threshold	1	1
Pacing Problem	1	1
Over-Sensing	1	1
Detachment of Device or Device Component	1	1
Insufficient Device Problem Information	1	1
Device Packaging Compromised	1	1
Unintended Ejection	1	1
Air/Gas in Device	1	1
No Audible Alarm	1	1
Defective Component	1	1
Failure to Transmit Record	1	1
Failure to Interrogate	1	1
Device Damaged Prior to Use	1	1
Poor Quality Image	1	1
Crack	1	2
Device Alarm System	1	1
Output Problem	1	1
Failure to Deliver Energy	1	1
Signal Artifact/Noise	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	238	239
No Known Impact Or Consequence To Patient	23	25
Cardiac Arrest	16	17
No Consequences Or Impact To Patient	13	13
Insufficient Information	8	8
No Patient Involvement	7	7
Ventricular Fibrillation	5	5
Asystole	5	5
Bradycardia	4	4
Arrhythmia	3	3
Pericardial Effusion	3	3
Heart Block	3	3
Complete Heart Block	2	2
Air Embolism	1	1
Stroke/CVA	1	1
Failure of Implant	1	1
Vascular Dissection	1	1
No Information	1	1
Atrial Fibrillation	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
Cardiopulmonary Arrest	1	1
Tissue Damage	1	1
Low Blood Pressure/ Hypotension	1	1
Ischemia Stroke	1	1