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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
IVY BIOMEDICAL SYSTEMS, INC.
  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
PHYSIO-CONTROL, INC.
  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
STRYKER PHYSIO-CONTROL
  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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 87 87
Device Operates Differently Than Expected 67 67
Failure to Capture 25 25
Connection Problem 10 10
Output Problem 10 10
Device Inoperable 10 10
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Defective Component 10 10
No Device Output 7 7
Device Sensing Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Communication or Transmission Problem 7 7
Failure of Device to Self-Test 5 5
Defective Device 5 5
Device Displays Incorrect Message 5 5
Sparking 5 5
Break 5 5
Loose or Intermittent Connection 4 4
Material Separation 4 4
Pacing Intermittently 4 4
Use of Device Problem 4 4
Peeled/Delaminated 3 3
Failure to Read Input Signal 3 3
Electrical /Electronic Property Problem 3 3
Detachment of Device or Device Component 3 3
Therapeutic or Diagnostic Output Failure 3 3
Intermittent Capture 3 3
Capturing Problem 3 3
Mechanical Problem 3 3
Inadequacy of Device Shape and/or Size 2 2
Incorrect Measurement 2 2
Optical Problem 2 2
Calibration Problem 2 2
Appropriate Term/Code Not Available 2 2
Physical Resistance/Sticking 2 2
Unable to Obtain Readings 2 2
No Pacing 2 2
Scratched Material 2 2
Device Alarm System 2 2
Smoking 2 2
Device Damaged Prior to Use 2 2
Human-Device Interface Problem 1 1
Overheating of Device 1 1
Failure to Form Staple 1 1
Intermittent Continuity 1 1
Difficult to Open or Close 1 1
Loss of Threshold 1 1
Pacing Problem 1 1
Corroded 1 1
Over-Sensing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 102 102
No Known Impact Or Consequence To Patient 85 85
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
Burn(s) 2 2
Bradycardia 2 2
Asystole 2 2
Arrhythmia 1 1
Not Applicable 1 1
Vascular Dissection 1 1
Burn, Thermal 1 1
Complete Heart Block 1 1
Cardiac Tamponade 1 1
Ventricular Fibrillation 1 1
Injury 1 1
Cardiac Perforation 1 1
Erythema 1 1
Discomfort 1 1
Cardiopulmonary Arrest 1 1
Physical Entrapment 1 1
Tissue Damage 1 1
Heart Block 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
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