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
BAYLIS MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
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 MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER PHYSIO-CONTROL
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	143	144
Blocked Connection	20	20
Incorrect, Inadequate or Imprecise Result or Readings	13	14
Connection Problem	10	10
Failure to Capture	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Loose or Intermittent Connection	8	8
Break	4	4
Therapeutic or Diagnostic Output Failure	4	4
Incorrect Measurement	4	4
No Device Output	3	3
Failure to Read Input Signal	3	3
Failure to Sense	3	3
Defective Device	3	3
Unable to Obtain Readings	3	3
Material Separation	3	3
Use of Device Problem	3	3
Mechanical Problem	2	2
Physical Resistance/Sticking	2	2
Defective Component	2	2
Detachment of Device or Device Component	2	2
Patient Device Interaction Problem	2	2
Calibration Problem	2	2
Noise, Audible	1	1
Loss of or Failure to Bond	1	1
Capturing Problem	1	1
Electrical /Electronic Property Problem	1	1
Overheating of Device	1	1
Component Incompatible	1	1
Nonstandard Device	1	1
Protective Measures Problem	1	1
Material Protrusion/Extrusion	1	1
Device Sensing Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Deformation	1	1
Device Difficult to Setup or Prepare	1	1
Unintended Ejection	1	1
Air/Gas in Device	1	1
No Audible Alarm	1	1
Failure to Transmit Record	1	1
Erratic Results	1	1
Insufficient Information	1	1
Unintended Movement	1	1
Poor Quality Image	1	1
Crack	1	2
Device Alarm System	1	1
Incomplete or Inadequate Connection	1	1
Communication or Transmission Problem	1	1
Device Slipped	1	1
Failure to Deliver Energy	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	216	217
Cardiac Arrest	8	9
Insufficient Information	7	7
Asystole	5	5
Ventricular Fibrillation	4	4
Pericardial Effusion	3	3
Bradycardia	3	3
Heart Block	3	3
Air Embolism	2	2
Arrhythmia	2	2
Stroke/CVA	1	1
Failure of Implant	1	1
Vascular Dissection	1	1
Atrial Fibrillation	1	1
Blister	1	1
Localized Skin Lesion	1	1
Transient Ischemic Attack	1	1
Burn(s)	1	1
Low Blood Pressure/ Hypotension	1	1
Ischemia Stroke	1	1