Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
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
884
884
2022
1548
1548
2023
1032
1032
2024
182
182
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1148
1148
Leak/Splash
508
508
Device Alarm System
463
463
Temperature Problem
370
370
Display or Visual Feedback Problem
262
262
Crack
216
216
Break
198
198
Power Problem
174
174
Mechanical Problem
160
160
No Audible Alarm
148
148
Defective Alarm
145
145
Insufficient Heating
128
128
Overheating of Device
123
123
Electrical /Electronic Property Problem
100
100
Failure to Power Up
100
100
False Alarm
98
98
Defective Component
97
97
Noise, Audible
91
91
Fracture
82
82
No Display/Image
79
79
Excessive Heating
79
79
Failure to Pump
69
69
Pumping Problem
68
68
Connection Problem
60
60
Failure to Calibrate
54
54
Infusion or Flow Problem
50
50
Material Separation
44
44
Device Sensing Problem
43
43
Display Difficult to Read
42
42
Pressure Problem
42
42
Defective Device
40
40
Output Problem
36
36
Audible Prompt/Feedback Problem
36
36
Improper Flow or Infusion
35
35
Calibration Problem
35
35
Component Missing
35
35
Device Damaged Prior to Use
33
33
Detachment of Device or Device Component
33
33
Insufficient Flow or Under Infusion
30
30
Patient Device Interaction Problem
30
30
Smoking
28
28
Alarm Not Visible
28
28
Circuit Failure
28
28
Key or Button Unresponsive/not Working
25
25
Insufficient Information
24
24
Failure to Deliver
23
23
Erratic or Intermittent Display
22
22
Failure to Sense
21
21
No Flow
21
21
Corroded
20
20
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Increase in Pressure
15
15
Fitting Problem
15
15
Device Displays Incorrect Message
15
15
Image Display Error/Artifact
15
15
Air/Gas in Device
15
15
No Visual Prompts/Feedback
14
14
Intermittent Loss of Power
13
13
Material Twisted/Bent
13
13
Naturally Worn
13
13
Contamination /Decontamination Problem
13
13
Material Fragmentation
12
12
Complete Loss of Power
12
12
Failure of Device to Self-Test
11
11
Grounding Malfunction
11
11
Obstruction of Flow
11
11
Use of Device Problem
10
10
No Audible Prompt/Feedback
10
10
Contamination
10
10
Fire
10
10
Appropriate Term/Code Not Available
10
10
No Tactile Prompts/Feedback
10
10
Device Difficult to Maintain
9
9
No Apparent Adverse Event
9
9
Device Fell
9
9
Electrical Power Problem
9
9
Disconnection
9
9
Device Emits Odor
9
9
Loose or Intermittent Connection
9
9
Device Difficult to Setup or Prepare
9
9
Unable to Obtain Readings
8
8
Failure to Infuse
8
8
Poor Quality Image
8
8
Electrical Shorting
8
8
Electrical Overstress
8
8
Protective Measures Problem
8
8
Material Integrity Problem
8
8
Flare or Flash
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Material Split, Cut or Torn
7
7
Particulates
7
7
Low Readings
7
7
Deformation Due to Compressive Stress
7
7
Sparking
6
6
Inaccurate Flow Rate
6
6
Material Discolored
6
6
Degraded
6
6
Failure to Conduct
6
6
Device Contamination with Chemical or Other Material
6
6
Material Deformation
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2675
2675
Insufficient Information
1160
1160
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
Death
5
5
Patient Problem/Medical Problem
4
4
Hypovolemic Shock
4
4
Urethral Stenosis/Stricture
3
3
Ruptured Aneurysm
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Ischemia
2
2
Exsanguination
2
2
Hemorrhage/Bleeding
2
2
Hypothermia
2
2
Aneurysm
2
2
Bruise/Contusion
2
2
Burn(s)
1
1
Cardiac Arrest
1
1
Adhesion(s)
1
1
Infiltration into Tissue
1
1
Electric Shock
1
1
Thrombosis/Thrombus
1
1
Skin Inflammation/ Irritation
1
1
Missing Value Reason
1
1
Not Applicable
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
-
-