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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transducer, blood-pressure, extravascular
Product CodeDRS
Regulation Number 870.2850
Device Class 2


Premarket Reviews
ManufacturerDecision
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
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 22 22
2015 60 60
2016 89 89
2017 92 92
2018 82 82
2019 84 84
2020 41 41
2021 93 93
2022 95 95
2023 152 152
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 122 122
Leak/Splash 110 110
Disconnection 104 104
Fluid/Blood Leak 99 99
Incorrect, Inadequate or Imprecise Result or Readings 65 65
Break 56 56
Detachment Of Device Component 49 49
Separation Failure 29 29
Detachment of Device or Device Component 20 20
Separation Problem 19 19
Air Leak 14 14
Pressure Problem 13 13
Unable to Obtain Readings 13 13
Incorrect Measurement 13 13
Crack 12 12
Device Contamination with Chemical or Other Material 12 12
Air/Gas in Device 10 10
Inaccurate Information 9 9
Connection Problem 9 9
High Readings 9 9
Device Operates Differently Than Expected 9 9
Failure to Reset 8 8
Particulates 8 8
Output Problem 8 8
Device Issue 7 7
Loss of or Failure to Bond 7 7
No Flow 7 7
Infusion or Flow Problem 7 7
Backflow 6 6
Display or Visual Feedback Problem 6 6
Mechanical Problem 6 6
Loose or Intermittent Connection 6 6
Device Markings/Labelling Problem 5 5
Reflux within Device 5 5
Device Sensing Problem 5 5
Device Displays Incorrect Message 4 4
Material Split, Cut or Torn 4 4
Failure to Zero 4 4
Difficult to Insert 4 4
Improper Flow or Infusion 3 3
Defective Device 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Difficult to Flush 3 3
Obstruction of Flow 3 3
Failure to Calibrate 3 3
Inappropriate Waveform 3 3
Tear, Rip or Hole in Device Packaging 3 3
Material Integrity Problem 3 3
Contamination 3 3
Device Inoperable 3 3
Failure to Prime 3 3
Burst Container or Vessel 2 2
Gas/Air Leak 2 2
Difficult to Remove 2 2
Display Difficult to Read 2 2
Fail-Safe Problem 2 2
Material Puncture/Hole 2 2
Activation, Positioning or Separation Problem 2 2
Incomplete or Inadequate Connection 2 2
Material Deformation 2 2
Hole In Material 2 2
No Device Output 2 2
Cut In Material 2 2
Nonstandard Device 2 2
Calibration Problem 2 2
Device Alarm System 2 2
Failure to Select Signal 1 1
Blood pooling 1 1
Dull, Blunt 1 1
Material Rupture 1 1
Failure to Analyze Signal 1 1
Blocked Connection 1 1
Incorrect Or Inadequate Test Results 1 1
Overheating of Device 1 1
Device Slipped 1 1
Device Packaging Compromised 1 1
Material Fragmentation 1 1
Mechanical Jam 1 1
Complete Blockage 1 1
Unintended Collision 1 1
Sticking 1 1
No Pressure 1 1
Unexpected Color 1 1
Reset Problem 1 1
Partial Blockage 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unintended Movement 1 1
Deflation Problem 1 1
Component Missing 1 1
Appropriate Term/Code Not Available 1 1
No Display/Image 1 1
Structural Problem 1 1
Melted 1 1
Physical Property Issue 1 1
Stopcock valve, failure of 1 1
Device Difficult to Program or Calibrate 1 1
Air eliminator, defective 1 1
Occlusion Within Device 1 1
Explosion 1 1
Priming Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 359 359
No Consequences Or Impact To Patient 300 300
No Known Impact Or Consequence To Patient 95 95
Blood Loss 46 47
No Patient Involvement 30 30
Insufficient Information 19 19
Hemorrhage/Bleeding 18 18
No Information 14 14
Death 6 6
Exposure to Body Fluids 3 3
Low Blood Pressure/ Hypotension 3 3
Not Applicable 3 3
Discomfort 2 2
Cardiac Arrest 2 2
Stroke/CVA 1 1
Edema 1 1
Extravasation 1 1
Burn(s) 1 1
Air Embolism 1 1
Anemia 1 1
Atrial Flutter 1 1
Complaint, Ill-Defined 1 1
Extubate 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Thrombosis 1 1
Respiratory Insufficiency 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Nov-05-2019
2 Edwards Lifesciences, LLC II Nov-29-2023
3 Edwards Lifesciences, LLC II Sep-11-2013
4 ICU Medical, Inc. II Mar-28-2019
5 ICU Medical, Inc. II Nov-15-2016
6 ICU Medical, Inc. II Sep-15-2016
7 ICU Medical, Inc. II Aug-07-2014
8 Smiths Medical ASD Inc. II Apr-21-2021
9 Smiths Medical Asd Inc II Jan-17-2024
10 Utah Medical Products, Inc II Jun-13-2013
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