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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device recorder, magnetic tape, medical
Regulation Description Medical magnetic tape recorder.
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BARDY DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 4
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
BIOTRICITY INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC INSIGHT, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K162503  Stealth System, Stealth Sensor, Stealth Smart Cabl ...
DMS-SERVICE LLC
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL INSTRUMENTATION LLC
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFELENS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PEERBRIDGE HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
QARDIO INC.
  SUBSTANTIALLY EQUIVALENT 1
SMART SOLUTIONS TECHNOLOGIES SL
  SUBSTANTIALLY EQUIVALENT 1
STRADOS LABS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 6 6
2017 31 31
2018 30 30
2019 76 76
2020 91 91
2021 88 88

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 289 289
Patient-Device Incompatibility 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Patient Data Problem 4 4
Appropriate Term/Code Not Available 2 2
Loss of or Failure to Bond 2 2
Electromagnetic Interference 1 1
False Negative Result 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Incorrect Interpretation of Signal 1 1
Failure to Sense 1 1
Output Problem 1 1
No Apparent Adverse Event 1 1
Defective Device 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Missing Information 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Display Difficult to Read 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 182 182
Skin Inflammation/ Irritation 109 109
No Known Impact Or Consequence To Patient 7 7
No Clinical Signs, Symptoms or Conditions 4 4
No Code Available 4 4
Blister 3 3
Swelling/ Edema 3 3
No Consequences Or Impact To Patient 3 3
Rash 3 3
Erythema 2 2
Itching Sensation 2 2
Pain 1 1
Scarring 1 1
Ventricle, Abnormality Of 1 1
Urticaria 1 1
Reaction 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Skin Disorders 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Death 1 1
Purulent Discharge 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Abrasion 1 1
Fluid Discharge 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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