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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
QUALITY IN FLOW LTD.
SUBSTANTIALLY EQUIVALENT
2
SMISSON-CARTLEDGE BIOMEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
THE SURGICAL COMPANY INTERNATIONAL B.V.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
94
94
2019
340
340
2020
1221
1221
2021
884
884
2022
1548
1548
2023
709
709
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1001
1001
Leak/Splash
505
505
Device Alarm System
424
424
Temperature Problem
361
361
Display or Visual Feedback Problem
239
239
Crack
187
187
Break
173
173
Power Problem
164
164
Mechanical Problem
158
158
No Audible Alarm
129
129
Defective Alarm
124
124
Overheating of Device
114
114
Insufficient Heating
111
111
Electrical /Electronic Property Problem
97
97
False Alarm
90
90
Failure to Power Up
88
88
Defective Component
85
85
Excessive Heating
85
85
Noise, Audible
76
76
No Display/Image
75
75
Fracture
64
64
Pumping Problem
64
64
Infusion or Flow Problem
52
52
Connection Problem
52
52
Failure to Pump
49
49
Failure to Calibrate
46
46
Pressure Problem
43
43
Defective Device
40
40
Display Difficult to Read
39
39
Device Sensing Problem
37
37
Output Problem
37
37
Improper Flow or Infusion
35
35
Audible Prompt/Feedback Problem
34
34
Calibration Problem
34
34
Material Separation
33
33
Device Damaged Prior to Use
33
33
Smoking
30
30
Insufficient Flow or Under Infusion
30
30
Patient Device Interaction Problem
30
30
Component Missing
29
29
Circuit Failure
29
29
Device Displays Incorrect Message
23
23
Failure to Deliver
20
20
Erratic or Intermittent Display
20
20
Detachment of Device or Device Component
19
19
Insufficient Information
18
18
No Flow
17
17
Appropriate Term/Code Not Available
16
16
Key or Button Unresponsive/not Working
16
16
Failure to Sense
16
16
Increase in Pressure
15
15
Alarm Not Visible
15
15
No Visual Prompts/Feedback
14
14
Material Twisted/Bent
13
13
Naturally Worn
13
13
Corroded
13
13
Fire
13
13
Image Display Error/Artifact
13
13
Device Emits Odor
13
13
Fitting Problem
12
12
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Contamination /Decontamination Problem
11
11
Material Fragmentation
11
11
Complete Loss of Power
11
11
Intermittent Loss of Power
11
11
No Tactile Prompts/Feedback
10
10
Failure of Device to Self-Test
10
10
Grounding Malfunction
10
10
Contamination
10
10
Obstruction of Flow
10
10
Use of Device Problem
10
10
No Audible Prompt/Feedback
10
10
Device Difficult to Setup or Prepare
9
9
Electrical Power Problem
9
9
Device Fell
9
9
Air/Gas in Device
9
9
No Apparent Adverse Event
9
9
Electrical Shorting
8
8
Protective Measures Problem
8
8
Material Integrity Problem
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Loose or Intermittent Connection
8
8
Thermal Decomposition of Device
8
8
Failure to Infuse
8
8
Sparking
7
7
Deformation Due to Compressive Stress
7
7
Unable to Obtain Readings
7
7
Failure to Conduct
7
7
Disconnection
7
7
Poor Quality Image
7
7
Particulates
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Material Deformation
7
7
Material Split, Cut or Torn
7
7
Flare or Flash
6
6
Inaccurate Flow Rate
6
6
Degraded
6
6
Material Discolored
5
5
Loss of Power
5
5
Electrical Overstress
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2332
2332
Insufficient Information
915
915
No Information
756
756
No Patient Involvement
514
514
No Consequences Or Impact To Patient
312
312
No Known Impact Or Consequence To Patient
287
287
No Code Available
6
6
Death
6
6
Hypovolemic Shock
4
4
Patient Problem/Medical Problem
4
4
Urethral Stenosis/Stricture
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Hypothermia
2
2
Ruptured Aneurysm
2
2
Ischemia
2
2
Injury
2
2
Electric Shock
2
2
Exsanguination
2
2
Hemorrhage/Bleeding
2
2
Aneurysm
2
2
Bruise/Contusion
2
2
Cardiac Arrest
2
2
Adhesion(s)
1
1
Burn(s)
1
1
Low Blood Pressure/ Hypotension
1
1
Superficial (First Degree) Burn
1
1
Shock
1
1
Unspecified Infection
1
1
Infiltration into Tissue
1
1
Thrombosis/Thrombus
1
1
Missing Value Reason
1
1
Not Applicable
1
1
Skin Inflammation/ Irritation
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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