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TPLC
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show TPLC since
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Device
probe, thermodilution
Product Code
KRB
Regulation Number
870.1915
Device Class
2
Premarket Reviews
Manufacturer
Decision
PULSION MEDICAL SYSTEMS SE
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
18
18
2019
26
26
2020
16
16
2021
22
22
2022
21
21
2023
13
13
2024
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
38
38
Material Fragmentation
28
28
Leak/Splash
27
27
Fluid/Blood Leak
11
11
Incorrect Measurement
10
10
Adverse Event Without Identified Device or Use Problem
6
6
Difficult to Insert
5
5
Material Integrity Problem
4
4
Fracture
4
4
Crack
3
3
Detachment of Device or Device Component
3
3
Connection Problem
3
3
Uncoiled
3
3
Disconnection
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Material Rupture
2
2
Sticking
2
2
Appropriate Term/Code Not Available
2
2
Material Frayed
1
1
Improper Device Output
1
1
Entrapment of Device
1
1
Incomplete or Missing Packaging
1
1
Device Alarm System
1
1
Insufficient Information
1
1
Defective Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
False Reading From Device Non-Compliance
1
1
Unable to Obtain Readings
1
1
Stretched
1
1
Material Twisted/Bent
1
1
Misconnection
1
1
Packaging Problem
1
1
Retraction Problem
1
1
Device Operates Differently Than Expected
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
70
70
No Consequences Or Impact To Patient
40
40
No Known Impact Or Consequence To Patient
12
12
Foreign Body In Patient
6
6
Ischemia
4
4
Insufficient Information
4
4
Device Embedded In Tissue or Plaque
4
4
Hemorrhage/Bleeding
3
3
Infarction, Cerebral
2
2
Vascular Dissection
2
2
Shock
2
2
Air Embolism
1
1
Occlusion
1
1
No Information
1
1
Hematoma
1
1
Thrombosis
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ICU Medical, Inc.
II
Dec-22-2018
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