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TPLC
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show TPLC since
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Device
warmer, thermal, infusion fluid
Product Code
LGZ
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
BARKEY GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
LIFE WARMER, INC.
SUBSTANTIALLY EQUIVALENT
2
MAC MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MEQU A/S
SUBSTANTIALLY EQUIVALENT
1
QUALITY IN FLOW LTD.
SUBSTANTIALLY EQUIVALENT
1
SMISSON-CARTLEDGE BIOMEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
THE SURGICAL COMPANY INTERNATIONAL B.V.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
340
340
2020
1221
1221
2021
885
885
2022
1548
1548
2023
1033
1033
2024
756
757
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1307
1307
Leak/Splash
519
519
Device Alarm System
513
513
Temperature Problem
404
404
Display or Visual Feedback Problem
284
284
Crack
244
244
Break
217
217
Power Problem
180
180
Defective Alarm
173
173
Insufficient Heating
167
167
No Audible Alarm
164
164
Mechanical Problem
163
163
Overheating of Device
129
129
False Alarm
114
114
Electrical /Electronic Property Problem
112
112
Fracture
108
108
Failure to Power Up
107
107
Defective Component
107
107
Noise, Audible
95
95
Excessive Heating
89
89
Failure to Pump
86
86
No Display/Image
85
85
Pumping Problem
71
71
Connection Problem
66
66
Failure to Calibrate
58
58
Infusion or Flow Problem
53
53
Device Sensing Problem
48
48
Defective Device
48
48
Display Difficult to Read
45
45
Material Separation
45
45
Pressure Problem
42
42
Component Missing
40
40
Key or Button Unresponsive/not Working
39
39
Output Problem
38
38
Detachment of Device or Device Component
37
38
Calibration Problem
37
37
Audible Prompt/Feedback Problem
36
36
Device Damaged Prior to Use
36
36
Improper Flow or Infusion
35
35
Alarm Not Visible
30
30
Patient Device Interaction Problem
30
30
Insufficient Flow or Under Infusion
30
30
Smoking
29
29
Failure to Sense
29
29
Circuit Failure
29
29
No Flow
28
28
Incorrect, Inadequate or Imprecise Result or Readings
28
28
Insufficient Information
26
26
Failure to Deliver
24
24
Erratic or Intermittent Display
22
22
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3179
3180
Insufficient Information
1232
1232
No Information
737
737
No Patient Involvement
510
510
No Consequences Or Impact To Patient
309
309
No Known Impact Or Consequence To Patient
218
218
No Code Available
5
5
Hypovolemic Shock
5
5
Death
5
5
Patient Problem/Medical Problem
4
4
Urethral Stenosis/Stricture
3
3
Exsanguination
3
3
Hemorrhage/Bleeding
2
2
Aneurysm
2
2
Bruise/Contusion
2
2
Hypothermia
2
2
Ischemia
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Ruptured Aneurysm
2
2
Thrombosis/Thrombus
1
1
Missing Value Reason
1
1
Not Applicable
1
1
Skin Inflammation/ Irritation
1
1
Hypovolemia
1
1
Electric Shock
1
1
Burn(s)
1
1
Cardiac Arrest
1
1
Infiltration into Tissue
1
1
Exposure to Body Fluids
1
1
Abrasion
1
1
Adhesion(s)
1
1
Hemothorax
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Eight Medical International BV
I
Jul-23-2021
2
RanD S.r.l.
II
Jul-09-2021
3
Smisson-Cartledge Biomedical, LLC
I
Mar-26-2021
4
Smiths Medical ASD Inc.
I
Sep-03-2021
5
Vyaire Medical
I
Jun-26-2019
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