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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
ACACIA, INC.
SUBSTANTIALLY EQUIVALENT
1
BARKEY GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
BELMONT INSTRUMENT CORP.
SUBSTANTIALLY EQUIVALENT
2
BELMONT INSTRUMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BIEGLER GMBH
SUBSTANTIALLY EQUIVALENT
1
CRECHE INNOVATIONS
SUBSTANTIALLY EQUIVALENT
1
EMIT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ENTHERMICS MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
HEI, INC.
SUBSTANTIALLY EQUIVALENT
1
IMPERIAL SURGICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
LIFE WARMER, INC.
SUBSTANTIALLY EQUIVALENT
2
MAC MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MEDICAL RESCUE EQUIPMENT HOLDING AS
SUBSTANTIALLY EQUIVALENT
1
NATUS NICOLET IRELAND LTD
SUBSTANTIALLY EQUIVALENT
1
QUALITY IN FLOW LTD.
SUBSTANTIALLY EQUIVALENT
5
RAND S.R.L.
SUBSTANTIALLY EQUIVALENT
2
SMISSON-CARTLEDGE BIOMEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
3
THE SURGICAL COMPANY INTERNATIONAL B.V.
SUBSTANTIALLY EQUIVALENT
1
THERMAL THERAPEUTIC SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
VITAL SIGNS, INC.
SUBSTANTIALLY EQUIVALENT
1
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
23
23
2015
34
34
2016
15
15
2017
58
58
2018
94
94
2019
340
340
2020
1221
1221
2021
884
884
2022
1548
1548
2023
1032
1032
2024
275
275
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1198
1198
Leak/Splash
539
539
Device Alarm System
478
478
Temperature Problem
382
382
Display or Visual Feedback Problem
267
267
Crack
224
224
Break
200
200
Power Problem
176
176
Mechanical Problem
160
160
Defective Alarm
153
153
No Audible Alarm
152
152
Overheating of Device
134
134
Insufficient Heating
131
131
Electrical /Electronic Property Problem
112
112
Failure to Power Up
104
104
Defective Component
99
99
False Alarm
99
99
Noise, Audible
95
95
Fracture
91
91
Excessive Heating
87
87
No Display/Image
84
84
Failure to Pump
73
73
Pumping Problem
70
70
Connection Problem
65
65
Infusion or Flow Problem
58
58
Failure to Calibrate
54
54
Pressure Problem
48
48
Device Sensing Problem
46
46
Material Separation
44
44
Display Difficult to Read
43
43
Defective Device
40
40
Output Problem
39
39
Improper Flow or Infusion
37
37
Component Missing
37
37
Smoking
37
37
Audible Prompt/Feedback Problem
36
36
Detachment of Device or Device Component
35
35
Calibration Problem
35
35
Device Damaged Prior to Use
34
34
Circuit Failure
31
31
Insufficient Flow or Under Infusion
30
30
Patient Device Interaction Problem
30
30
Alarm Not Visible
29
29
Device Displays Incorrect Message
28
28
Insufficient Information
27
27
Key or Button Unresponsive/not Working
27
27
Incorrect, Inadequate or Imprecise Result or Readings
24
24
Failure to Sense
23
23
Failure to Deliver
23
23
Erratic or Intermittent Display
22
22
No Flow
21
21
Corroded
20
20
Disconnection
18
18
Image Display Error/Artifact
16
16
Fire
16
16
Increase in Pressure
16
16
Device Emits Odor
16
16
Appropriate Term/Code Not Available
16
16
Air/Gas in Device
15
15
Fitting Problem
15
15
Use of Device Problem
14
14
No Visual Prompts/Feedback
14
14
Material Twisted/Bent
14
14
Device Operates Differently Than Expected
14
14
Contamination /Decontamination Problem
13
13
Adverse Event Without Identified Device or Use Problem
13
13
Naturally Worn
13
13
Intermittent Loss of Power
13
13
Contamination
13
13
Material Fragmentation
12
12
Complete Loss of Power
12
12
Obstruction of Flow
12
12
Failure of Device to Self-Test
11
11
Grounding Malfunction
11
11
No Audible Prompt/Feedback
11
11
Sparking
11
11
Loose or Intermittent Connection
10
10
Thermal Decomposition of Device
10
10
No Apparent Adverse Event
10
10
No Tactile Prompts/Feedback
10
10
Device Difficult to Maintain
9
9
Device Fell
9
9
Material Integrity Problem
9
9
Electrical Power Problem
9
9
Poor Quality Image
9
9
Device Difficult to Setup or Prepare
9
9
Unable to Obtain Readings
8
8
Failure to Infuse
8
8
Electrical Shorting
8
8
Electrical Overstress
8
8
Device Contamination with Chemical or Other Material
8
8
Deformation Due to Compressive Stress
8
8
Material Deformation
8
8
Protective Measures Problem
8
8
Material Split, Cut or Torn
7
7
Flare or Flash
7
7
Manufacturing, Packaging or Shipping Problem
7
7
Low Readings
7
7
Loss of Power
7
7
Particulates
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2748
2748
Insufficient Information
1183
1183
No Information
765
765
No Patient Involvement
519
519
No Known Impact Or Consequence To Patient
367
367
No Consequences Or Impact To Patient
333
333
Death
10
10
No Code Available
7
7
Patient Problem/Medical Problem
4
4
Hypothermia
4
4
Hypovolemic Shock
4
4
Bruise/Contusion
3
3
Low Blood Pressure/ Hypotension
3
3
Electric Shock
3
3
Urethral Stenosis/Stricture
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Not Applicable
2
2
Blood Loss
2
2
Injury
2
2
Ruptured Aneurysm
2
2
Burn(s)
2
2
Cardiac Arrest
2
2
Aneurysm
2
2
Exsanguination
2
2
Hemorrhage/Bleeding
2
2
Ischemia
2
2
Shock
1
1
Swelling
1
1
Tachycardia
1
1
Unspecified Infection
1
1
Infiltration into Tissue
1
1
Hypoglycemia
1
1
Adhesion(s)
1
1
Thrombosis/Thrombus
1
1
Missing Value Reason
1
1
Partial thickness (Second Degree) Burn
1
1
Respiratory Failure
1
1
Rupture
1
1
Complaint, Ill-Defined
1
1
Superficial (First Degree) Burn
1
1
Skin Inflammation/ Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Eight Medical International BV
I
Jul-23-2021
2
Enginivity LLC
II
Sep-04-2009
3
Natus Manufacturing Limited
II
Jan-06-2017
4
RanD S.r.l.
II
Jul-09-2021
5
Smisson-Cartledge Biomedical, LLC
I
Mar-26-2021
6
Smiths Medical ASD Inc.
I
Sep-03-2021
7
Smiths Medical ASD, Inc.
III
Feb-07-2017
8
Smiths Medical ASD, Inc.
II
Apr-09-2014
9
Smiths Medical ASD, Inc.
II
Jul-09-2012
10
Smiths Medical ASD, Inc.
II
Jan-11-2012
11
Steris Corporation
II
Jan-06-2016
12
Vital Signs Devices, a GE Healthcare Company
II
Jul-09-2012
13
Vital Signs Devices, a GE Healthcare Company
II
Aug-19-2011
14
Vital Signs Inc
II
Sep-03-2010
15
Vyaire Medical
I
Jun-26-2019
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