TPLC - Total Product Life Cycle

show TPLC since

Device	transducer, blood-pressure, extravascular
Product Code	DRS
Regulation Number	870.2850
Device Class	2

Premarket Reviews
Manufacturer	Decision
B. BRAUN MELSUNGEN AG
	SUBSTANTIALLY EQUIVALENT	1
BIOMETRIX LTD.
	SUBSTANTIALLY EQUIVALENT	1
CENTURION MEDICAL PRODUCTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL A.C.A.L
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL PTE. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIRADOR BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MIRADOR BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
REAVILLMED
	SUBSTANTIALLY EQUIVALENT	1
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	147	147
Fluid/Blood Leak	144	144
Disconnection	115	115
Leak/Splash	109	109
Break	72	72
Incorrect, Inadequate or Imprecise Result or Readings	65	65
Detachment Of Device Component	48	48
Separation Failure	29	29
Separation Problem	25	25
Detachment of Device or Device Component	23	23
Air/Gas in Device	23	23
Crack	19	19
Inaccurate Information	16	16
Incorrect Measurement	15	15
Unable to Obtain Readings	14	14
Pressure Problem	13	13
No Flow	12	12
Air Leak	12	12
Connection Problem	11	11
Device Contamination with Chemical or Other Material	11	11
High Readings	10	10
Output Problem	8	8
Loss of or Failure to Bond	7	7
Device Issue	7	7
Device Operates Differently Than Expected	7	7
Infusion or Flow Problem	7	7
Particulates	7	7
Backflow	7	7
Material Split, Cut or Torn	6	6
Mechanical Problem	6	6
Display or Visual Feedback Problem	6	6
Failure to Reset	6	6
Reflux within Device	5	5
Device Sensing Problem	5	5
Device Markings/Labelling Problem	5	5
Failure to Zero	5	5
Device Displays Incorrect Message	4	4
Loose or Intermittent Connection	4	4
Difficult to Insert	4	4
Material Integrity Problem	4	4
Contamination	3	3
Failure to Calibrate	3	3
No Device Output	3	3
Device Inoperable	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Difficult to Flush	3	3
Defective Device	3	3
Obstruction of Flow	3	3
Failure to Prime	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	498	498
No Consequences Or Impact To Patient	295	295
No Known Impact Or Consequence To Patient	85	85
Blood Loss	43	44
No Patient Involvement	30	30
Hemorrhage/Bleeding	26	26
Insufficient Information	24	24
No Information	11	11
Death	4	4
Not Applicable	3	3
Exposure to Body Fluids	3	3
Low Blood Pressure/ Hypotension	3	3
Cardiac Arrest	2	2
Thrombosis/Thrombus	2	2
Discomfort	2	2
Patient Problem/Medical Problem	1	1
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Complaint, Ill-Defined	1	1
Pneumothorax	1	1
Anemia	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Burn(s)	1	1
Extravasation	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Atrial Flutter	1	1
Full thickness (Third Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1