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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device esophageal thermal regulation and gastric suctioning device
Regulation Description Esophageal thermal regulation device.
Definition The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.
Product CodePLA
Regulation Number 870.5910
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED COOLING THERAPY, INC. D/B/A ATTUNE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED COOLING THERAPY, LLC
  SUBSTANTIALLY EQUIVALENT 2
ATTUNE MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 3 3
2018 2 2
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 2 2
Fluid Leak 2 2
Temperature Problem 1 1
Insufficient Cooling 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Electrolyte Imbalance 2 2
Alteration In Body Temperature 2 2
Laceration(s) 1 1
Laceration(s) of Esophagus 1 1
Choking 1 1

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