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TPLC
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show TPLC since
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Device
monitor, ultrasonic, nonfetal
Product Code
JAF
Regulation Number
892.1540
Device Class
2
Premarket Reviews
Manufacturer
Decision
THD SPA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
7
7
2016
5
5
2017
44
44
2018
1
1
2019
2
2
2020
5
5
2021
1
1
2022
2
2
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Sensing Problem
44
44
Device Operates Differently Than Expected
3
3
Break
3
3
No Audible Prompt/Feedback
3
3
Failure to Select Signal
2
2
Device Inoperable
2
2
Device Displays Incorrect Message
2
2
Malposition of Device
1
1
Communication or Transmission Problem
1
1
Loss of Data
1
1
Use of Device Problem
1
1
Inaudible or Unclear Audible Prompt/Feedback
1
1
Defective Device
1
1
No Display/Image
1
1
Inflation Problem
1
1
Loose or Intermittent Connection
1
1
Misconnection
1
1
No Device Output
1
1
Unable to Obtain Readings
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Environmental Compatibility Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Misassembly by Users
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
52
52
No Consequences Or Impact To Patient
6
6
No Clinical Signs, Symptoms or Conditions
3
3
Air Embolism
2
2
Burn(s)
1
1
Cardiac Arrest
1
1
Nausea
1
1
No Patient Involvement
1
1
Superficial (First Degree) Burn
1
1
Partial thickness (Second Degree) Burn
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Natus Neurology Inc
II
Jul-13-2017
2
Unetixs Vascular, Inc.
II
Mar-01-2023
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