• 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 electrode, electrocardiograph, multi-function
Product CodeMLN
Regulation Number 870.2360
Device Class 2

MDR Year MDR Reports MDR Events
2017 19 19
2018 14 14
2019 11 11
2020 1 1
2021 7 7
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Sense 7 7
Device Operates Differently Than Expected 6 6
Device Sensing Problem 6 6
Failure of Device to Self-Test 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Connection Problem 4 4
Appropriate Term/Code Not Available 4 4
Insufficient Information 3 3
Sparking 2 2
Arcing of Electrodes 2 2
Bent 2 2
Failure to Deliver Shock/Stimulation 2 2
Failure to Discharge 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Fire 1 1
Gel Leak 1 1
Mechanical Problem 1 1
Device Emits Odor 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Analyze Signal 1 1
Break 1 1
Incomplete or Missing Packaging 1 1
Material Protrusion/Extrusion 1 1
Patient-Device Incompatibility 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 27 27
No Clinical Signs, Symptoms or Conditions 8 8
Skin Tears 5 5
No Patient Involvement 4 4
Superficial (First Degree) Burn 3 3
No Information 3 3
Burn(s) 3 3
Insufficient Information 3 3
Cardiac Arrest 2 2
Death 2 2
Erythema 1 1
Itching Sensation 1 1
Burn, Thermal 1 1
Abrasion 1 1
Atrial Fibrillation 1 1
No Code Available 1 1
Respiratory Arrest 1 1
Unspecified Respiratory Problem 1 1
Blister 1 1
Skin Burning Sensation 1 1
Partial thickness (Second Degree) Burn 1 1

-
-