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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
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
ENERGETIC DESIGNS, 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 CHANGKE CONNECT ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN CORERAY TECHNOLOGY., LTD
  SUBSTANTIALLY EQUIVALENT 2
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
2017 5 5
2018 15 15
2019 11 11
2020 31 31
2021 9 9
2022 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 20 20
Failure to Capture 16 16
Adverse Event Without Identified Device or Use Problem 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Material Separation 4 4
Break 4 4
Pacing Intermittently 4 4
Connection Problem 4 4
Detachment of Device or Device Component 3 3
Device Operates Differently Than Expected 3 3
Therapeutic or Diagnostic Output Failure 3 3
Peeled/Delaminated 3 3
No Device Output 3 3
Loose or Intermittent Connection 3 3
Defective Component 3 3
Defective Device 2 2
Unable to Obtain Readings 2 2
Inadequacy of Device Shape and/or Size 2 2
Intermittent Capture 2 2
Output Problem 2 2
Scratched Material 2 2
Device Damaged Prior to Use 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 1 1
No Pacing 1 1
Patient Device Interaction Problem 1 1
Device Packaging Compromised 1 1
Device Sensing Problem 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Protrusion/Extrusion 1 1
Incorrect Measurement 1 1
Corroded 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
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Device Slipped 1 1
Loss of Threshold 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of or Failure to Bond 1 1
Failure to Read Input Signal 1 1
Device Displays Incorrect Message 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 24 24
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 13 13
No Patient Involvement 10 10
Cardiac Arrest 8 8
Insufficient Information 3 3
Bradycardia 2 2
Arrhythmia 1 1
Vascular Dissection 1 1
No Information 1 1
Pericardial Effusion 1 1
Swelling/ Edema 1 1
Cardiopulmonary Arrest 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 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
4 Volcano Corp III Apr-12-2022
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