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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cable, electrode
Product CodeIKD
Regulation Number 890.1175
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 57 57
2017 33 33
2018 5 5
2019 4 4
2020 7 7
2021 11 11
2022 17 17
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Break 12 12
Device Operates Differently Than Expected 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Overheating of Device 4 4
Pacing Problem 3 3
Disconnection 3 3
Mechanical Problem 3 3
Melted 3 3
Insufficient Information 3 3
Communication or Transmission Problem 3 3
Failure to Conduct 2 2
Device Displays Incorrect Message 2 2
Detachment of Device or Device Component 2 2
Failure to Deliver Energy 2 2
False Positive Result 2 2
Thermal Decomposition of Device 2 2
Misconnection 2 2
Defibrillation/Stimulation Problem 2 2
Use of Device Problem 2 2
Defective Component 1 1
Invalid Sensing 1 1
Device Issue 1 1
High Readings 1 1
Low Readings 1 1
High Sensing Threshold 1 1
Low Sensing Threshold 1 1
Defective Device 1 1
Nonstandard Device 1 1
Material Separation 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Failure to Capture 1 1
Circuit Failure 1 1
Device Reprocessing Problem 1 1
Material Disintegration 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Fracture 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Capturing Problem 1 1
No Pacing 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 87 87
No Clinical Signs, Symptoms or Conditions 29 29
No Consequences Or Impact To Patient 7 7
Insufficient Information 4 4
No Patient Involvement 3 3
Arrhythmia 3 3
Cardiac Arrest 2 2
Complete Heart Block 2 2
Not Applicable 1 1
No Information 1 1
No Code Available 1 1
Limb Fracture 1 1
Death 1 1
Fainting 1 1
Hypoxia 1 1
Pain 1 1
Scarring 1 1
Skin Irritation 1 1
Burn(s) 1 1
Cardiac Perforation 1 1
Diminished Pulse Pressure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Sep-20-2021
2 Ad-Tech Medical Instrument Corporation II Apr-15-2016
3 GE Healthcare, LLC III Mar-26-2019
4 Oscor, Inc. I Apr-10-2017
5 St. Jude Medical II Aug-05-2011
6 Sterilmed Inc II Jan-13-2009
7 Vermed, Inc. II May-04-2011
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