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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
Incorrect Measurement 13 13
Unable to Obtain Readings 13 13
Pressure Problem 13 13
Device Contamination with Chemical or Other Material 12 12
Crack 12 12
Air/Gas in Device 10 10
Inaccurate Information 9 9
Connection Problem 9 9
Device Operates Differently Than Expected 9 9
High Readings 9 9
Failure to Reset 8 8
Particulates 8 8
Output Problem 8 8
No Flow 7 7
Infusion or Flow Problem 7 7
Loss of or Failure to Bond 7 7
Device Issue 7 7
Display or Visual Feedback Problem 6 6
Mechanical Problem 6 6
Loose or Intermittent Connection 6 6
Backflow 6 6
Reflux within Device 5 5
Device Sensing Problem 5 5
Device Markings/Labelling Problem 5 5
Material Split, Cut or Torn 4 4
Difficult to Insert 4 4
Failure to Zero 4 4
Device Displays Incorrect Message 4 4
Inappropriate Waveform 3 3
Defective Device 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Inoperable 3 3
Obstruction of Flow 3 3
Failure to Calibrate 3 3
Contamination 3 3
Difficult to Flush 3 3
Failure to Prime 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Improper Flow or Infusion 3 3
Material Integrity Problem 3 3
Material Deformation 2 2
Gas/Air Leak 2 2
Activation, Positioning or Separation Problem 2 2
Fail-Safe Problem 2 2
Incomplete or Inadequate Connection 2 2
No Device Output 2 2
Nonstandard Device 2 2
Hole In Material 2 2
Display Difficult to Read 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Cut In Material 2 2
Calibration Problem 2 2
Material Puncture/Hole 2 2
Difficult to Remove 2 2
Failure to Analyze Signal 1 1
Material Rupture 1 1
Failure to Sense 1 1
Air eliminator, defective 1 1
Stopcock valve, failure of 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Blood pooling 1 1
Failure to Select Signal 1 1
Device Slipped 1 1
Sticking 1 1
Blocked Connection 1 1
Structural Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Dull, Blunt 1 1
Bent 1 1
Partial Blockage 1 1
Complete Blockage 1 1
No Display/Image 1 1
Decoupling 1 1
Deflation Problem 1 1
Fracture 1 1
Material Fragmentation 1 1
Material Frayed 1 1
False Reading From Device Non-Compliance 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Occlusion Within Device 1 1
Unintended Collision 1 1
Overheating of Device 1 1
Device Difficult to Program or Calibrate 1 1
Priming Problem 1 1
Unexpected Color 1 1
No Pressure 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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