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TPLC
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show TPLC since
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Device
monitor and/or control, level sensing, cardiopulmonary bypass
Product Code
DTW
Regulation Number
870.4340
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
11
11
2016
22
22
2017
47
47
2018
6
6
2019
15
15
2020
2
2
2021
2
2
2023
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operational Issue
15
15
Device Alarm System
10
10
Device Displays Incorrect Message
9
9
False Alarm
8
8
Device Operates Differently Than Expected
8
8
Device Sensing Problem
7
7
No Display/Image
7
7
Failure to Power Up
6
6
Failure To Adhere Or Bond
5
5
Failure to Sense
5
5
Break
4
4
Appropriate Term/Code Not Available
4
4
Pumping Stopped
3
3
Other (for use when an appropriate device code cannot be identified)
3
3
Connection Problem
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Delayed Alarm
2
2
Failure to Auto Stop
2
2
Disconnection
1
1
Pressure Problem
1
1
Insufficient Information
1
1
False Reading From Device Non-Compliance
1
1
Degraded
1
1
Out-Of-Box Failure
1
1
Bent
1
1
Low Readings
1
1
Incorrect Measurement
1
1
No Flow
1
1
Output Problem
1
1
Communication or Transmission Problem
1
1
Material Integrity Problem
1
1
Under-Sensing
1
1
Failure to Calibrate
1
1
Over-Sensing
1
1
Defective Alarm
1
1
Device Stops Intermittently
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
56
56
No Patient Involvement
42
42
No Clinical Signs, Symptoms or Conditions
5
5
No Known Impact Or Consequence To Patient
3
3
No Information
2
2
No Patient involvement
2
2
Patient Problem/Medical Problem
1
1
Seizures
1
1
Insufficient Information
1
1
Ventilator Dependent
1
1
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