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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
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

MDR Year MDR Reports MDR Events
2019 2 2
2022 1 1
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Fluid/Blood Leak 1 1
Temperature Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bradycardia 1 1
Fistula 1 1
Hematoma 1 1
Hypothermia 1 1
Laceration(s) 1 1
Laceration(s) of Esophagus 1 1
Hypervolemia 1 1
Alteration In Body Temperature 1 1
Gastrointestinal Hemorrhage 1 1
Insufficient Information 1 1

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