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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)
Regulation Description Patient transducer and electrode cable (including connector).
Product CodeDSA
Regulation Number 870.2900
Device Class 2


Premarket Reviews
ManufacturerDecision
APK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATRILITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AUTHENTIC MEDICAL
  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
INTEGRAL PROCESS SAS
  SUBSTANTIALLY EQUIVALENT 1
JKH USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC , INC.
  SUBSTANTIALLY EQUIVALENT 1
ORANTECH 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
TIGER MEDICAL PRODUCTS
  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
2016 28 28
2017 5 5
2018 15 15
2019 11 11
2020 31 31
2021 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 21 21
Failure to Capture 16 16
Output Problem 9 9
Device Operates Differently Than Expected 7 7
Connection Problem 6 6
Device Sensing Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Defective Component 5 5
Sparking 5 5
Loose or Intermittent Connection 4 4
Pacing Intermittently 4 4
Peeled/Delaminated 3 3
No Device Output 3 3
Therapeutic or Diagnostic Output Failure 3 3
Scratched Material 2 2
Device Damaged Prior to Use 2 2
Failure of Device to Self-Test 2 2
Detachment of Device or Device Component 2 2
Intermittent Capture 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Smoking 2 2
Loss of Threshold 1 1
Device Inoperable 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Capturing Problem 1 1
Communication or Transmission Problem 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Failure to Form Staple 1 1
Arcing 1 1
Break 1 1
Incorrect Measurement 1 1
Corroded 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Material Discolored 1 1
Display or Visual Feedback Problem 1 1
Failure to Interrogate 1 1
Overheating of Device 1 1
Over-Sensing 1 1
Pacing Problem 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Packaging Compromised 1 1
Human-Device Interface Problem 1 1
No Pacing 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 34 34
No Consequences Or Impact To Patient 22 22
No Patient Involvement 13 13
Cardiac Arrest 12 12
No Clinical Signs, Symptoms or Conditions 5 5
Bradycardia 2 2
Burn(s) 1 1
Arrhythmia 1 1
Vascular Dissection 1 1
No Information 1 1
Pericardial Effusion 1 1
Insufficient Information 1 1
Cardiopulmonary Arrest 1 1
Erythema 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Cardiac Tamponade 1 1
Discomfort 1 1
Injury 1 1
Cardiac Perforation 1 1
Burn, Thermal 1 1
Complete Heart Block 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC III Jun-26-2019
2 GN Otometrics II Sep-23-2019
3 Philips North America, LLC II Sep-09-2019
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