Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device cable, transducer and electrode, patient, (including connector)
Product CodeDSA
Regulation Number 870.2900
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATRILITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AUTHENTIC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING RONGRUI-CENTURY SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURBELL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENERGETIC DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOGG SYSTEM COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRAL PROCESS SAS
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
KEPLER MEDTEC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC , INC.
  SUBSTANTIALLY EQUIVALENT 1
ORANTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
QT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CAREMED MEDICAL TECHNOLOGY 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 2
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
  SUBSTANTIALLY EQUIVALENT 1
TIGER MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
TYCO ELECTRONICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNIMED MEDICAL SUPPLIES INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
XINKANG MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 67 67
2015 33 33
2016 28 28
2017 5 5
2018 15 15
2019 11 11
2020 31 31
2021 7 7
2022 50 50
2023 29 29
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 72 72
Device Operates Differently Than Expected 67 67
Failure to Capture 25 25
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Output Problem 10 10
Device Inoperable 10 10
Defective Component 10 10
Connection Problem 10 10
Communication or Transmission Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Device Sensing Problem 7 7
Failure of Device to Self-Test 5 5
Device Displays Incorrect Message 5 5
Sparking 5 5
No Device Output 5 5
Break 5 5
Loose or Intermittent Connection 4 4
Pacing Intermittently 4 4
Material Separation 4 4
Defective Device 4 4
Capturing Problem 3 3
Detachment of Device or Device Component 3 3
Use of Device Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Failure to Read Input Signal 3 3
Mechanical Problem 3 3
Peeled/Delaminated 3 3
Electrical /Electronic Property Problem 3 3
Intermittent Capture 3 3
Device Alarm System 2 2
Incorrect Measurement 2 2
Unable to Obtain Readings 2 2
Inadequacy of Device Shape and/or Size 2 2
Scratched Material 2 2
Smoking 2 2
Device Damaged Prior to Use 2 2
Calibration Problem 2 2
No Pacing 2 2
Physical Resistance/Sticking 2 2
Incomplete or Inadequate Connection 1 1
Patient Device Interaction Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Loss of Threshold 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Failure to Form Staple 1 1
Arcing 1 1
Optical Problem 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Patient Data Problem 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Difficult to Open or Close 1 1
Electrical Shorting 1 1
Device Packaging Compromised 1 1
Device Slipped 1 1
Failure to Transmit Record 1 1
Poor Quality Image 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Overheating of Device 1 1
Over-Sensing 1 1
Pacing Problem 1 1
Unintended Ejection 1 1
Failure to Interrogate 1 1
Loss of or Failure to Bond 1 1
Charred 1 1
Intermittent Continuity 1 1
Corroded 1 1
Crack 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Material Discolored 1 1
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 85 85
No Clinical Signs, Symptoms or Conditions 83 83
No Consequences Or Impact To Patient 51 51
No Patient Involvement 30 30
Cardiac Arrest 16 16
Insufficient Information 4 4
No Information 2 2
Pericardial Effusion 2 2
Asystole 2 2
Bradycardia 2 2
Burn(s) 2 2
Arrhythmia 1 1
Cardiopulmonary Arrest 1 1
Erythema 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Cardiac Tamponade 1 1
Physical Entrapment 1 1
Discomfort 1 1
Injury 1 1
Cardiac Perforation 1 1
Burn, Thermal 1 1
Complete Heart Block 1 1
Heart Block 1 1
Vascular Dissection 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Jan-07-2011
2 GE Healthcare, LLC III Jun-26-2019
3 GN Otometrics II Sep-23-2019
4 Philips North America, LLC II Sep-09-2019
5 Remington Medical Inc. II Apr-09-2014
6 Remington Medical Inc. II Aug-13-2010
7 Volcano Corp III Apr-12-2022
-
-