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TPLC
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show TPLC since
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2024
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Device
analyzer, gas, oxygen, gaseous-phase
Product Code
CCL
Regulation Number
868.1720
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-MED DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
CAREOX, LLC
SUBSTANTIALLY EQUIVALENT
1
ENVITEC-WISMAR GMBH
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
3
PRECISION MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
5
5
2016
1
1
2017
2
2
2018
1
1
2019
1
1
2020
1
1
2021
3
3
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Flow or Under Infusion
3
3
Insufficient Information
2
2
Device Inoperable
2
2
Device Operates Differently Than Expected
2
2
Device Displays Incorrect Message
2
2
High Readings
1
1
Application Program Problem: Dose Calculation Error
1
1
Incorrect Measurement
1
1
No Apparent Adverse Event
1
1
No Display/Image
1
1
Failure to Deliver
1
1
Sparking
1
1
Communication or Transmission Problem
1
1
Device Sensing Problem
1
1
Inaccurate Flow Rate
1
1
Material Integrity Problem
1
1
Calibration Problem
1
1
Device Expiration Issue
1
1
Improper Flow or Infusion
1
1
Output Problem
1
1
Defective Device
1
1
Failure to Analyze Signal
1
1
Device Alarm System
1
1
Partial Blockage
1
1
Leak/Splash
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6
6
No Consequences Or Impact To Patient
5
5
No Information
4
4
No Known Impact Or Consequence To Patient
3
3
No Patient Involvement
2
2
Death
2
2
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Hypersensitivity/Allergic reaction
1
1
Respiratory Distress
1
1
Misdiagnosis
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GE Healthcare
II
May-28-2015
2
GE Healthcare, LLC
II
Sep-09-2014
3
GE Healthcare, LLC
II
Jun-17-2014
4
Teleflex Medical
II
Dec-29-2009
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